Omnimax S3, Omnimax S4

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable. December 22, 2023 SharpLight Technologies Ltd Rada Trifonov RA Manager 33 Lazarov St Rishon Le Zion, 7565435 Israel Re: K233304 Trade/Device Name: Omnimax S3, Omnimax S4 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX, GEI, NUV, ONG, ONE, ONF Dated: September 29, 2023 Received: September 29, 2023 Dear Rada Trifonov: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Shlomit Digitally signed by Shlomit Halachmi -S Halachmi -S Date: 2023.12.22 06:43:50 -05'00' For Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices {2}------------------------------------------------ OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K233304 Device Name Omnimax Device Series #### Indications for Use (Describe) The Omnimax Device Series along with its optional Handpieces, uses IPL, IR, Laser and RF technologies and is intended for use in aesthetic and cosmetic applications and in selective treatments in medical specialties of dermatology, through the transmission of energy to human skin. Intense Pulsed Light (IPL-DPC) with 415 – 1200 mm wavelengths (with and without contact-cooling) handpieces are indicated for: * Hair removal and Permanent Hair Reduction in all skin types (I-V) to the Fitzpatrick scale - Recommended wavelengths in the range of 635-950 nm or 580-950 nm. * Flow Mode is suitable for Fitzpatrick skin types I-VI. Recommended wavelength: 635nm-950mm. * Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (1-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 580-950 mm. * Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm. * Treatment of Benign Pigmented Epidermal, Cutaneous and Vascular Lesions including warts; scars and striae in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-680 nm & 860-1200mm. * Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale – Recommended wavelength in the range of 415-950 nm. Infrared (IR) with 850 - 1750 nm wavelengths (with contact cooling) handpieces is indicated for: * Dermatologic Treatment such as, but not limited to: photocoagulation of soft tissue (Scars, Wrinkles, Rhytids and Periorbital Wrinkles). Radio Frequency (RF) handpieces are indicated for: * Treatment of mild to moderate facial wrinkles and rhytids for all skin types. Nd: Y AG Laser 1064 nm Long Pulse (LP) handpiece is indicated for: * Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. * Removal or lightening of unwanted hair. * Treatment of pseudofolliculitis barbae (PFB). * Benign vascular lesions such as, but not limited to treatment of: Port wine stains: Hemangiomas; Warts, Superficial and deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas. * Benign cutaneous lesions, such as, but not limited to: Warts; Scars; Striae; Psoriasis. * Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lat macules; Sebortheic; keratoses; Nevi and nevus of Ota, Chloasma; Verrucae; Skin tags; Plaques. * Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment and for patients with lesions that have not responded to other laser treatments. * The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles. * Laser skin resurfacing procedures for the treatment of: Acne scars; Wrinkles. * Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. * Indicated for use on all skin types (Fitzpatrick I-VI). {4}------------------------------------------------ Nd:YAG 1064 nm O-Switched Laser with optional 532 nm Frequency Doubler (FD) handpiece indicated for: * The removal of black, blue or green tattoos (significant reduction in the intensity of black tattoos); * Tattoo removal: Light blue; Yellow; Red; Green. * Benign pigmented lesions, such as, but not limited to: Cafe-au-lat (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevus spillus, Nevus of Ota; Becker's Nevi. * Other pigmented cutaneous lesions, such as, but not limited to: Verrucae; Skin tags; Keratoses; Plaques. Er: YAG Laser 2940 nm Long Pulse (LP), with standard and scanner accessory tips handpiece is indicated for: * Use in soft tissue (skin, cutaneous tissue) for Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars). Type of Use (Select one or both, as applicable) |X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ Image /page/5/Picture/0 description: The image features the logo for Sharplight, a company that appears to be in the beauty industry. The logo consists of a geometric shape at the top, resembling a multifaceted gem or crystal, with colors ranging from red and pink to orange and purple. Below the shape, the company name "SHARPLIGHT" is written in bold, sans-serif font. Underneath the name, the tagline "the beauty of your success" is displayed in a smaller, italicized font, suggesting the company's focus on enhancing beauty and achieving success. #### 510K Summary | Applicant Information | | |------------------------|-----------------------------------------------------------| | Applicant Information | SharpLight Technologies Ltd. | | | 33 Lazarov St. | | | Rishon Le Zion 7565435, Israel | | | Tel: (972) 3-961-1969 | | | Fax: (972) 3-952-8890 | | Contact Person | Rada Trifonov | | | 33 Lazarov St. | | | Rishon Le Zion 7565435, Israel | | | Tel: (972)- 547797218 | | Date Prepared | September 29, 2023 | | Device Common Name | Omnimax Device Series | | Classification | | | Product Code | Primary GEX, Secondary GEI, NUV, ONG, ONE, ONF | | Regulation No. | 21 CFR § 878.4810 | | Class | II | | Panel | General & Plastic Surgery | | Regulation Description | Laser Surgical Instrument, for use in General and Plastic | | | Surgery and Dermatology | # Identification of Legally Marketed Predicate Devices | SharpLight – Dermatological Treatment Device Family | K111303 | |-----------------------------------------------------|---------| | Pollogen – Apollo System | K111026 | Page 1 of 11 SharpLight Technologies Ltd. 33 Lazarov, Rishon Lezion, Israel {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Sharplight. The logo features a geometric shape made up of several polygons in shades of pink, orange, and purple. Below the shape, the word "SHARPLIGHT" is written in a sans-serif font, and below that is the tagline "the beauty of your success" in a smaller, italicized font. ### Device Description The Omnimax Device Series, which includes the Omnimax S3 and S4 devices, is a multiapplication, multi-technology platform designed for skin treatments and various aesthetic and dermatological applications. This is achieved by applying light energy (IPL, IR, and Laser) and Radio Frequency (RF) to the human skin. Each device in the series features the following technologies: The Omnimax S4 incorporates IPL-DPC, IR, RF, and Laser technologies. The Omnimax S3 incorporates IPL-DPC, IR, and RF technologies. The Omnimax Device Series modification enhances capabilities of the legally cleared Dermatological Treatment Device Family (K111303) by adding RF functionality with optional handpieces in addition to the previously cleared IPL, Laser and IR technology. The system consists of: - a) Main unit (includes controller) - b) Control Panel (UI) - c) RF Module - d) Display Unit - e) Footswitch - Trolley f) - g) 14 Handpieces/applicators: - IPL-DPC 7 Handpieces ● - IR 2 Handpieces . - Laser 3 Handpieces ● - RF 2 Handpieces ● The main unit is a platform system with embedded software, designed to support all treatment technologies and handpieces (i.e. IPL-DPC, IR, Laser and RF). {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Sharplight. The logo features a geometric shape at the top, composed of triangular facets in shades of red, orange, pink, and purple. Below the shape, the word "SHARPLIGHT" is written in a bold, sans-serif font. Underneath "SHARPLIGHT" is the tagline "the beauty of your success" in a smaller, italicized font. #### Intended Use The Omnimax Device Series along with its optional Handpieces, uses IPL, IR, Laser and RF technologies and is intended for use in aesthetic and cosmetic applications and in selective treatments in medical specialties of dermatology, through the transmission of energy to human skin. #### Indications for use and patient population Intense Pulsed Light (IPL-DPC) with 415 – 1200 nm wavelengths (with and without contact-cooling) handpieces are indicated for: * Hair removal and Permanent Hair Reduction in all skin types (I-V) to the Fitzpatrick scale - Recommended wavelengths in the range of 635-950 nm, 730-950 nm or 580-950 nm. * Flow Mode is suitable for Fitzpatrick skin types I-VI. Recommended wavelength: 635nm-950nm. * Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 580-950 nm. * Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm. * Treatment of Benign Pigmented Epidermal, Cutaneous and Vascular Lesions including warts: scars and striae in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-680 nm & 860-1200nm. * Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 415-950 nm. Infrared (IR) with 850 - 1750 nm wavelengths (with contact cooling) handpieces is indicated for: * Dermatologic Treatment such as, but not limited to: photocoagulation of soft tissue (Scars, Wrinkles, Rhytids and Periorbital Wrinkles). {8}------------------------------------------------ Image /page/8/Picture/0 description: The image features the logo for Sharplight, a company whose tagline is "the beauty of your success." The logo consists of a geometric shape resembling a multifaceted gem or crystal, composed of several triangular sections in shades of pink, orange, and purple. Below the geometric shape, the company name "SHARPLIGHT" is written in a bold, sans-serif font, with the tagline appearing in a smaller, italicized font underneath. Radio Frequency (RF) handpieces are indicated for: * Treatment of mild to moderate facial wrinkles and rhytids for all skin types. #### Nd: YAG Laser 1064 nm Long Pulse (LP) handpiece is indicated for: * Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. * Removal or lightening of unwanted hair. * Treatment of pseudofolliculitis barbae (PFB). * Benign vascular lesions such as, but not limited to treatment of: Port wine stains; Hemangiomas: Warts, Superficial and deep telangiectasias (venulectasias): Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas. * Benign cutaneous lesions, such as, but not limited to: Warts; Scars; Striae; Psoriasis. * Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Seborrheic; keratoses; Nevi and nevus of Ota, Chloasma; Verrucae; Skin tags; Keratoses; Plaques. * Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment and for patients with lesions that have not responded to other laser treatments. * The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles; Perioral wrinkles. * Laser skin resurfacing procedures for the treatment of: Acne scars; Wrinkles. * Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. * Indicated for use on all skin types (Fitzpatrick I-VI). Nd:YAG 1064 nm Q-Switched Laser with optional 532 nm Frequency Doubler (FD) handpiece indicated for: Page 4 of 11 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image features the logo for "SHARPLIGHT," accompanied by the tagline "the beauty of your success." Above the text, there is a geometric shape resembling a multifaceted gem or crystal, composed of triangular sections in shades of red, pink, orange, and purple. The logo is clean and modern, with a focus on the geometric shape and the company name. * The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); * Tattoo removal: Light blue; Yellow; Red; Green. * Benign pigmented lesions, such as, but not limited to: Cafe-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus. Nevus of Ota; Becker's Nevi. * Other pigmented cutaneous lesions, such as, but not limited to: Verrucae; Skin tags; Keratoses: Plaques. Er:YAG Laser 2940 nm Long Pulse (LP), with standard and scanner accessory tips handpiece is indicated for: * Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue) for Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars). # Technological Characteristics The Omnimax Device Series shares the same intended use and indications for IPL, IR, Laser and RF technologies as its predicate devices. Furthermore, the technological characteristics and operational principles of the Omnimax Device Series align with those of the predicate devices. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image features the logo for Sharplight, a company that emphasizes beauty and success. The logo consists of a geometric shape resembling a multifaceted gem or crystal, with sections colored in shades of pink, purple, and orange. Below the geometric shape, the company name "SHARPLIGHT" is written in a bold, sans-serif font, and underneath the name is the tagline "the beauty of your success" in a smaller, lighter font. Comparison table of the technological characteristics is provided as follows: | | Proposed Device | | Predicate 1 | Predicate 2 | Characteristic<br>Comparison<br>(same/different) | |--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Common Device Name | Omnimax Series Device Family<br>(Trade name: Omnimax S3,<br>Omnimax S4) | | Dermatologic Treatment System<br>Device family | Apollo System | N/A | | Manufacturer | | Sharplight Technologies Ltd. | Sharplight Technologies Ltd. | Pollogen Ltd. | | | 510(k) Number | TBD | | K111303 | K111026 | | | Device Class | Class II | | Class II | Class II | Same | | Classification<br>Panel | General and Plastic<br>Surgery | | General and Plastic<br>Surgery | General and Plastic<br>Surgery | Same | | Product code | GEX, GEI | | GEX | GEI | Same per<br>technology | | Device main components | h) Main unit (includes controller)<br>i) Control Panel (UI)<br>j) RF Unit<br>k) Display Unit<br>l) Footswitch<br>m) Trolley<br>n) 14 handpieces/applicators:<br>IPL-DPC – 7<br>IR – 2<br>Laser - 3<br>RF – 2 handpieces | | a) Main unit (includes controller)<br>b) Control Panel (UI)<br>c) Display Unit<br>d) Footswitch<br>e) Trolley<br>f) 12 handpieces/applicators:<br>IPL-DPC - 7<br>IR – 2<br>Laser - 3 | a) Main Unit (includes<br>controller)<br>b) Control Panel (UI)<br>c) RF Unit<br>d) Footswitch<br>e) Patient Controlled<br>Manual Switch<br>f) 3 handpieces/<br>applicators:<br>g) RF - 3<br>(2 of which are being<br>compared) | Same per<br>technology | | Supported technologies | IPL-DPC, IR, Laser, RF | | IPL-DPC, IR, Laser | RF | Same per<br>technology | | Wavelength Spectrum | IPL-DPC<br>IR | 415 - 1200 nm<br>850 - 1750 nm | 415 - 1200 nm<br>850 - 1750 nm | N/A | Same<br>Same | | | Proposed Device | Predicate 1 | Predicate 2 | Characteristic<br>Comparison<br>(same/different) | | | | ER:Yag<br>Laser 2940<br>2940 nm | 2940 nm | | Same | | | | Nd:Yag<br>LP Laser<br>1064 nm | 1064 nm | | Same | | | | Q-<br>Switched<br>Laser<br>532 and 1064 nm | 532 and 1064 nm | | Same | | | Fluence/ Power | IPL-DPC<br>5 - 25 J/cm² | 5 - 30 J/cm² | N/A | Same, within<br>predicate 1 limits | | | | IR<br>15 - 60 J/cm² | 5 - 80 J/cm² | | Same, within<br>predicate 1 limits | | | | ER:Yag<br>Laser 2940<br>0.2-2.6 J | 0.2J-1.2 J | | Same lower limit,<br>different upper<br>limit, no impact on<br>safety or efficacy | | | | Nd:Yag<br>LP Laser<br>30 - 350 J/cm² | 30 - 450 J/cm² | | Same, within<br>predicate 1 limits | | | | Q-<br>Switched<br>Laser<br>0.4-1.4 J | 0.2-1.2 J | | Different, no<br>impact on safety or<br>efficacy | | | | RF<br>Up to 50 W | N/A | Up to 50 W | Same | | | | Proposed Device | Predicate 1 | Predicate 2 | Characteristic<br>Comparison<br>(same/different) | | | Pulse Width | IPL-DPC | 10-100 msec | 6-100 msec | N/A | Same, within<br>predicate 1 limits | | | IR | 4-6 sec | 2 - 6 sec | | Different, no<br>impact on safety or<br>efficacy | | | ER:Yag<br>Laser 2940 | 0.2-2 ms | 0.2-2 ms | | Same | | | Nd:Yag<br>LP Laser | 4-30 ms | 10, 40, 60, 100 ms | | Same, within<br>predicate 1 limits | | | Q-<br>Switched<br>Laser | 10 ns | 20 ns | | Different, no<br>impact on safety or<br>efficacy | | | RF | Continual | N/A | Continual | Same | | Spot size | IPL-DPC | 1.5, 3.4, 6.4 cm2 | 1.5, 3.4, 6.4 cm2 | N/A | Same | | | IR | 3.4, 6.4 cm2 | 1.5, 3.4, 6.4 cm2 | | Same. 1.5 cm2 was<br>removed. | | | ER:Yag<br>Laser 2940 | 7*7 mm<br>9*9 mm | 7*7 mm<br>9*9 mm<br>1, 2, 4 mm | | Same. 1, 2 mm<br>were removed. | | | Nd:Yag<br>LP Laser | 3, 6 mm | 2, 3, 4, 6 mm | | Same for 3, 6 mm,<br>2, 4 mm were<br>removed. | | | Q-<br>Switched<br>Laser | 2, 4, 6, 12 mm | 1, 2, 4, 6 mm | | Same for 2, 4, 6<br>mm, different for<br>12 mm with no<br>impact on safety or<br>efficacy. 1 mm<br>was removed. | | | RF | 3.5 (S), 5.5 (L) cm | N/A | 3.5, 5.5 cm | Same | | | Proposed Device | | Predicate 1 | Predicate 2 | Characteristic<br>Comparison<br>(same/different) | | Repetition rate | IPL-DPC | 0.4-0.66 Hz | 0.4 Hz | | Same lower limit,<br>different upper<br>limit, no impact on<br>safety or efficacy. | | | IR<br>ER:Yag<br>Laser 2940 | N/A<br>1-4 Hz | N/A<br>1-3 Hz | N/A | N/A<br>Same lower limit,<br>different upper<br>limit, no impact on<br>safety or efficacy. | | | Nd:Yag<br>LP Laser | Up to 1 Hz | Up to 1 Hz | | Same | | | Q-<br>Switched<br>Laser | 1-5 Hz | 1-3 Hz | | Different, no<br>impact on safety or<br>efficacy | | | RF | 1Mhz | N/A | 1Mhz | Same | | Target Treatment<br>Population | Fitzpatrick Skin Types I-VI, most hair<br>color and skin treatment (vascular<br>lesions, pigmented lesions,<br>photorejuvenation and acne).<br>Adult population. | | Fitzpatrick Skin Types I-VI, most hair<br>color and skin treatment (vascular<br>lesions, pigmented lesions,<br>photorejuvenation and acne).<br>Adult population. | Adult population. | Same per<br>technology | | Materials | Metal, Plastic, Electronic, Laser and<br>optic components and heat exchanger. | | Metal, Plastic, Electronic, Laser and<br>optic components and heat exchanger. | Metal, Plastic, Electronic,<br>optic components and heat<br>exchanger. | Same per<br>technology | | Coolant Method | Cooling system, treatment gel or air<br>cooling (as required per technology) | | Cooling system, treatment gel or air<br>cooling (as required per technology) | Air cooling | Same per<br>technology | | Anatomical sites | Skin | | Skin | Skin | Same | Page 6 of 11 {11}------------------------------------------------ Image /page/11/Picture/0 description: The image features the logo for Sharplight, a company that appears to be in the beauty industry. The logo consists of a geometric shape resembling a multifaceted gem or crystal, with sections colored in shades of orange, pink, and purple. Below the geometric shape, the company name "SHARPLIGHT" is written in a bold, sans-serif font, and underneath the name is the tagline "the beauty of your success" in a smaller, italicized font. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image features the logo for Sharplight, a company that appears to be in the beauty industry. The logo consists of a geometric shape resembling a multifaceted gem or crystal, with sections colored in shades of orange, pink, and purple. Below the geometric shape, the company name "SHARPLIGHT" is written in a bold, sans-serif font, and underneath the name is the tagline "the beauty of your success" in a smaller, italicized font. Page 8 of 11 SharpLight Technologies Ltd. 33 Lazarov, Rishon Lezion, Israel {13}------------------------------------------------ Image /page/13/Picture/0 description: The image contains the logo for Sharplight. The logo features a geometric shape at the top, composed of triangular facets in shades of pink, orange, and purple. Below the shape, the word "SHARPLIGHT" is written in a bold, sans-serif font, and underneath that, the tagline "the beauty of your success" is written in a smaller, lighter font. {14}------------------------------------------------ Image /page/14/Picture/0 description: The image contains the logo for Sharplight. The logo consists of a geometric shape made up of several triangles in different colors, including orange, pink, and purple. Below the shape is the word "SHARPLIGHT" in a sans-serif font, and below that is the tagline "the beauty of your success" in a smaller, italicized font. #### Performance Standards The subsequent assessments were conducted to confirm the validity of the device and the additional modifications made: - . Risk analysis activities in compliance with ISO 14971. - Electrical safety in accordance with IEC 60601-1 and EMC in accordance with IEC . 60601-1-2. - Laser compatibility testing as required to conform with IEC 60601-2-22 and IEC . 60825-1. - IPL compatibility testing as required to conform with IEC 60601-2-57. . - RF compatibility testing as required to conform with IEC 60601-2-2. . #### Clinical Performance Data The Omnimax device Series contains 4 technologies: IPL, IR, Laser and RF. Regarding IPL, IR and Laser, the Omnimax Series Device Family is the same as the Dermatological Treatment Device Family device family (i.e.: same performance & technological characteristics, same Handpieces, etc.). Therefore, in regard to those technologies, no additional performance or clinical testing is required. Regarding the RF function of the device series, the safety and efficacy of radiofrequency devices emitting energy with a frequency of 1 MHz and power of 50W is well established in scientific research and clinical studies. Multiple studies with these and similar systems have shown safety in dermatologic therapy and the devices were cleared by the FDA for therapy of wrinkles and rhytids. Due to the comprehensive studies performed in scientific, research and published in the literature and since the power and frequency of the Omnimax Device Series are within the range of previously cleared values, animal and clinical studies are not required to determine the safety and efficacy of the device. {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the logo for Sharplight. The logo features a geometric shape made up of several polygons in shades of pink, orange, and purple. Below the shape, the word "SHARPLIGHT" is written in a sans-serif font, and below that is the tagline "the beauty of your success" in a smaller, italicized font. # Conclusions Based on the above, the proposed Omnimax Device series is substantially equivalent in terms technology, intended use, performance features and safety and effectiveness to the predicate devices: Dermatological Treatment Device Family (K111303) and the Apollo System (K111026).