DEKA TORO

{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 Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 16, 2024 El.En. S.p.A. Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FI 50141 Italy Re: K240752 Trade/Device Name: Deka Toro 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 Dated: March 19, 2024 Received: March 19, 2024 Dear Paolo Peruzzi: 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. {1}------------------------------------------------ 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" (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 QS 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). {2}------------------------------------------------ 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-devices/deviceadvice-comprehensive-regulatory-assistance/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. Digitally signed Tanisha L. by Tanisha L. Hithe -S Hithe -S Date: 2024.05.16 12:49:41 -04'00' Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & 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) K240752 Device Name Deka Toro # Indications for Use (Describe) 785 nm laser source Intended for removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 1064 & 532 nm laser sources in Q-Switched, nanosecond mode Intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to: 532 nm (Q-Switched, nanosecond mode), including microbeam handpieces: - · Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos - · Treatment of benign vascular lesions including, but not limited to: - port wine birthmarks - telangiectasias - spider angioma - Cherry angioma - Spider nevi - · Treatment of benign pigmented lesions including, but not limited to: - cafe-au-Iait birthmarks - Ephalides, solar lentigines - senile lentigines - Becker's nevi - freckles - common nevi - nevus spilus - Ota Nevus - · Treatment of seborrheic keratosis - · Treatment of post inflammatory hyperpigmentation - · Skin resurfacing procedures for the treatment of acne scars and wrinkles. 1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces: - · Removal of dark ink (black, blue and brown) tattoos - · Removal of benign pigmented lesions including; - nevus of Ota - Café au lait spot - Ephalides, solar lentigo (lentigines) - Becker Nevus - Nevus spilus - · Treatment of common nevi - · Removal or lightening of unwanted hair - · Skin resurfacing procedures for the treatment of acne scars and wrinkles 1064nm laser source in thermal mode (long-pulse) Intended for: - Treatment of wrinkles - · Treatment of mild to moderate inflammatory acne vulgaris {4}------------------------------------------------ X Prescription Use (Part 21 CFR 801 Subpart D) #### 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}------------------------------------------------ # 510(k) Summary # K240752 ## DEKA TORO ### Submitter: El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy ### Contact: Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi@elen.it ### Date Summary Prepared: March 19, 2024 ### Device Trade Name: DEKA TORO ### Common Name: Medical Laser system #### Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology #### Product Code: GEX #### Regulatory Class: Class II #### Regulation Number: 21 CFR 878.4810 ## Predicate Devices: QUANTA SYSTYEM CHROME (K202503) LUTRONIC HOLLYWOOD SPECTRA (K213569) LASEROPTEK HELIOS 785 Pico (K230373) {6}------------------------------------------------ # Device Description: TORO device is a DEKA laser system with a wide choice of emission modes, ranging from picosecond to hundreds of microseconds of pulse duration. The available sources are Nd:YAG lasers at 532 nm and 1064 nm, operating in Q-switched mode, and Ti:Sapphire laser at 785 nm operating in the Picosecond pulse mode. The Q-switched laser at 1064 nm can also operate in Thermal mode, delivering pulses of hundreds of microseconds. The laser beam generated by the source is then optically coupled to the articulated arm with a handpiece plugged at its end and delivered to the Patient. ## Indications for Use: #### 785 nm laser source Intended for removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. #### 1064 & 532 nm laser sources in Q-Switched, nanosecond mode Intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to: 532 nm (Q-Switched, nanosecond mode), including microbeam handpieces: - Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos - . Treatment of benign vascular lesions including, but not limited to: - । port wine birthmarks - telangiectasias । - । spider angioma - Cherry angioma ー - l Spider nevi - Treatment of benign pigmented lesions including, but not limited to: ● - cafe-au-lait birthmarks - Ephalides, solar lentigines — - senile lentigines - -Becker's nevi - freckles - common nevi - nevus spilus - Ota Nevus l - Treatment of seborrheic keratosis - Treatment of post inflammatory hyperpigmentation - Skin resurfacing procedures for the treatment of acne scars and wrinkles. 1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces: - . Removal of dark ink (black, blue and brown) tattoos {7}------------------------------------------------ - Removal of benign pigmented lesions including; ● - । nevus of Ota - Café au lait spot । - । Ephalides, solar lentigo (lentigines) - | Becker Nevus - । Nevus spilus - Treatment of common nevi - . Removal or lightening of unwanted hair - Skin resurfacing procedures for the treatment of acne scars and wrinkles ## 1064nm laser source in thermal mode (long-pulse) Intended for: - Treatment of wrinkles - Treatment of mild to moderate inflammatory acne vulgaris # Comparison with The Predicate Device: ### 785nm laser source | | Proposed device<br>DEKA Toro | K230373<br>HELIOS 785 Pico<br>Ti:Sapphire laser (785nm) | COMMENTS | |--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------| | INDICATIONS FOR USE | Removal of tattoos for Fitzpatrick<br>skin types II-IV to treat the<br>following tattoo colors: green and<br>blue. | Removal of tattoos for Fitzpatrick<br>skin types II-IV to treat the<br>following tattoo colors: green and<br>blue. | Identical | | Product Code | GEX | GEX | Identical | | Classification | Class II | Class II | Identical | | Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical | | Wavelength (nm) | 785nm ± 25 nm | 785nm ±20% | Identical | | Pulse Duration | 600 - 900 ps | 600 ps | Similar | | Pulse Energy (max) | 0.2 J | 0.2 J | Identical | | Fluence (max) | 4 J/cm² | 4 J/cm² | Identical | | Max Peak Power | 0.33 GW | 0.33 GW | Identical | | Max Average Power | 1 W | 2 W | Subset, within the<br>range of the predicate | | Spot Size (mm) | 2-6 mm | 1-8 mm | Subset, within the<br>range of the predicate | | Repetition Rate (Hz) | 1-5 Hz | 1-10 Hz | Subset, within the<br>range of the predicate | | Beam Delivery System | Articulated Arm with Handpiece | Articulated Arm with Handpiece | Identical | | | Proposed device<br>DEKA TORO | K202503 CHROME<br>1064 & 532 nm (Q-Switched, nanosecond<br>mode) | COMMENTS | | INDICATIONS<br>FOR USE | Treatment of benign vascular lesions,<br>benign pigmented lesions, and for hair,<br>tattoo removal and the incision, excision,<br>ablation, vaporization of soft tissue for<br>General dermatology such as, but not<br>limited to:<br>532 nm including microbeam handpieces:<br>Removal of light ink (red, sky blue, green,<br>tan, purple, and orange) tattoos<br>Treatment of benign vascular lesions<br>including, but not limited to:<br>- port wine birthmarks<br>- telangiectasias<br>- spider angioma<br>- Cherry angioma<br>- Spider nevi<br>Treatment of benign pigmented lesions<br>including, but not limited to:<br>- cafe-au-lait birthmarks<br>- Ephalides, solar lentigines<br>- senile lentigines<br>- Becker's nevi<br>- freckles<br>- common nevi<br>- nevus spilus<br>- Ota Nevus<br>Treatment of seborrheic keratosis<br>Treatment of post inflammatory<br>hyperpigmentation<br>Skin resurfacing procedures for the<br>treatment of acne scars and wrinkles.<br>1064 nm including microbeam<br>handpieces:<br>Removal of dark ink (black, blue and<br>brown) tattoos<br>Removal of benign pigmented lesions<br>including;<br>- nevus of Ota<br>- Café au lait spot<br>- Ephalides, solar lentigo (lentigines)<br>- Becker Nevus<br>- Nevus spilus<br>Treatment of common nevi<br>Removal or lightening of unwanted hair<br>Skin resurfacing procedures for the<br>treatment of acne scars and wrinkles | Treatment of benign vascular lesions,<br>benign pigmented lesions, and for hair,<br>tattoo removal and the incision, excision,<br>ablation, vaporization of soft tissue for<br>General dermatology such as, but not<br>limited to treatment of:<br>532 nm including microbeam handpieces:<br>Removal of light ink (red, sky blue, green,<br>tan, purple, and orange) tattoos<br>Treatment of benign vascular lesions<br>including, but not limited to:<br>- port wine birthmarks<br>- telangiectasias<br>- spider angioma<br>- Cherry angioma<br>- Spider nevi<br>Treatment of benign pigmented lesions<br>including, but not limited to:<br>- cafe-au-lait birthmarks<br>- Ephalides, solar lentigines<br>- senile lentigines<br>- Becker's nevi<br>- freckles<br>- common nevi<br>- nevus spilus<br>- Ota Nevus<br>Treatment of seborrheic keratosis<br>Treatment of post inflammatory<br>hyperpigmentation<br>Skin resurfacing procedures for the<br>treatment of acne scars and wrinkles.<br>1064 nm including microbeam<br>handpieces:<br>Removal of dark ink (black, blue and<br>brown) tattoos<br>Removal of benign pigmented lesions<br>including;<br>- nevus of Ota<br>- Café au lait spot<br>- Ephalides, solar lentigo (lentigines)<br>- Becker Nevus<br>- Nevus spilus<br>Treatment of common nevi<br>Removal or lightening of unwanted hair<br>Skin resurfacing procedures for the<br>treatment of acne scars and wrinkles | Identical | | | Proposed device<br>DEKA TORO | K202503 CHROME<br>1064 & 532 nm (Q-Switched, nanosecond<br>mode) | COMMENTS | | Product Code | GEX | GEX | Identical | | Classification | Class II | Class II | Identical | | Regulation<br>Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical | | Wavelength | 1064, 532 nm | 1064, 532 nm | Identical | | Pulse Duration | 5 - 12 ns @1064 nm<br>5 - 12 ns @532 nm | 6 - 12 ns @1064<br>6 - 12 ns @532nm | Similar | | Pulse Energy<br>(max) | 1.0 J @ 1064 nm<br>0.5 J @ 532 nm | 1.0 J @1064<br>0.5 J @532…