Diode Laser Therapy Device

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration". April 17, 2020 Shanghai Apolo Medical Technology Co., Ltd. Ms. Claire Zhang Manager Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Building 1, West Guangzhong Road 555, Jingan District Shanghai. 200071 CN Re: K200118 Trade/Device Name: Diode Laser Therapy Device 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: January 15, 2020 Received: January 21, 2020 Dear Claire Zhang: 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 (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 located 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. 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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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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, Colin Kejing Chen Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K200118 Device Name Diode Laser Therapy Devices #### Indications for Use (Describe) The Diode Laser Therapy Device is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | 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." {3}------------------------------------------------ # K200118-510(k) summary ### l Submitter Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District, Shanghai 200231, China Preparation Date: Apr.16, 2020 Establishment Registration Number: 3007120647 Contact person: Felix Li Position: Regulatory Affairs Phone: +86-138 4919 0618 Fax: +86-21-34622840 E-mail: liqiang@apolo.com.cn ### II Proposed Device | Trade Name of Device: | Diode Laser Therapy Device | |-----------------------|-----------------------------------| | Common name: | Powered Laser Surgical Instrument | | Regulation Number: | 21 CFR 878.4810 | | Regulatory Class: | Class II | | Product code: | GEX | | Review Panel | General & Plastic Surgery | ### III Predicate Devices | 510(k) Number: | K172193 | |-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade name: | Modified Alma Lasers Soprano XL™Family of<br>Multi-Application and Multi-Technology Platforms<br>[SopranoXL, SopranoXLi, Soprano ICE and Soprano ICE Platinum] with Trio Diode LaserModule | | Common name: | Powered Laser Surgical Instrument | | Classification: | Class II | | Product Code: | GEX | | Manufacturer | Alma Lasers Inc. | ### IV Device description The Diode Laser Therapy Devices is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective {4}------------------------------------------------ photothermolysis. The wavelength of 810nm, 755, and 1064nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system. The proposed device includes power supply system, delivery system, control system, cooling system, laser system. The 755nm, 810nm, 1064nm handpieces with different treatment size are available for different models. # V Indication for use The Diode Laser Therapy Device is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin. | Item | Proposed device | Predicate device<br>(K172193) | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product name | Diode Laser Therapy Device | Modified Alma Lasers<br>Soprano XL™Family of<br>Multi-Application and<br>Multi-Technology<br>Platforms [SopranoXL,<br>SopranoXLi, Soprano<br>ICE and Soprano ICE<br>Platinum] with Trio<br>Diode LaserModule | | Product Code | GEX | GEX | | Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | | Class | Class II | Class II | | Indication for use | The Diode Laser Therapy Device is<br>indicated for permanent reduction in hair<br>regrowth defined as a long term, stable<br>reduction in the number of hairs re-growing<br>when measured at 6,9 and 12 months after<br>the completion of a treatment regimen. It is<br>suitable for all skin types (Fitzpatrick skin | Intended use:<br>The device is intended<br>for use in dermatologic<br>and general surgical<br>procedures.<br>Indication for use: | | type I-VI), including tanned skin. | The Soprano trio Diode Laser Module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio Diode Laser Module include: Benign vascular and vascular dependent lesions removal. The indications for use for the Soprano 1064nm Diode Laser Module include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Treatment of Pseudo folliculitis Barbae (PFB) Use on all skin types (Fitzpatrick I-VI), including tanned skin | | | | The indications for use<br>for the 810nm Modified<br>Diode Laser Module<br>1.2cm² include:<br>• The Hair Removal<br>(HR) and Super<br>Hair Removal<br>(SHR) Mode are<br>intended for<br>permanent<br>reduction in hair<br>regrowth defined as<br>a long term, stable<br>reduction in the<br>number of hairs<br>re-growing when<br>measured at 6,9<br>and 12 months after<br>the completion of a<br>treatment regimen.<br>• The treatment of<br>benign vascular and<br>pigmented<br>lesions.(The Laser<br>Blanch (LB) Mode)<br>• Use on all skin<br>types (Fitzpatrick<br>I-VI), including<br>tanned skin. (HR,<br>SHR and LB<br>Modes)<br>Optional Tapered Light<br>Guide: It is intended for<br>the same use as the<br>device.<br>The indications for use<br>for the 810nm Modified<br>Diode Laser Module 2<br>cm² include: | | | | The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes) The indications for use for the 755nm Diode Laser Module include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a | | | | treatment regimen.<br>The treatment of<br>benign vascular and<br>pigmented<br>lesions.(The Laser<br>Blanch Mode)<br>Use on all skin<br>●<br>types (Fitzpatrick<br>I-VI),<br>including<br>tanned to a<br>skin. (HR, | | | | SHR and Laser<br>Blanch Modes) | | | | NIR Modules<br>The Alma Lasers NIR<br>Modules intended use is<br>to emit energy in the<br>near infrared (NIR)<br>spectrum to provide<br>topical heating.<br>The indications for use | | | | for NIR Modules are:<br>Elevating the tissue<br>temperature for the<br>temporary relief of | | | | minor muscle pain<br>and joint pain and<br>stiffness, | | | | The temporary relief<br>●<br>of minor joint pain<br>associated<br>with<br>arthritis, | | | | The The<br>temporary<br>●<br>increase in local<br>circulation where<br>applied, and | | | | The relaxation of<br>muscles; may also<br>help<br>muscle<br>spasms,<br>minor | | VI Comparison of technological characteristics with the predicate devices {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ | | | | | | sprains and strains, and minor muscular back pain. | |-----------------------------|--------------------------------------------------------|-------------------------|------------------------|-------------------------|--------------------------------------------------------------------------------------------------------------------| | Laser<br>Type | | Solid state | | | Solid state | | Light<br>Delivery<br>system | 755nm handpiece<br>810nm handpiece<br>1064nm handpiece | | | | 755nm module<br>810nm module<br>1064nm module<br>Soprano trio diode laser module<br>NIR Modules | | Handpiece tip<br>material | Sapphire | | | | Sapphire | | Controls | Footswitch or handpiece | | | | Footswitch or handpiece | | Handpiece | HS-810N & 811N | HS-812N | HS-816 & 818 | HS-817 & 819 | Soptano titanium | | Spot size | 12x18m;<br>12x30 mm; | 12x20mm;<br>15x40 mm; | 12x14m;<br>10x10 mm | 12x16m;<br>12x20 mm | ALEX 755nm handpiece: 15 x10mm;<br>Speed 810nm handpiece 20 x10mm<br>Trio handpiece:2cm². | | Energy<br>density | 1~110J/cm² | 1~62J/cm²<br>1~40 J/cm² | 1~72J/cm²<br>1~60J/cm² | 1~62J/cm²<br>1~64 J/cm² | 120J/ cm², 150J/cm² (optional). | | Pulse<br>width | 10-400ms | 10-300ms;<br>1-200ms. | 1-200ms;<br>1-100ms | 10-300ms | 810,755nm: 3.3~200;<br>1064nm: 3.3~280<br>Trio:40-800ms | | Pulse<br>frequency | 1, 2, 3, 5, 8, 10HZ. | 1,2,3,5,8, 10,15HZ | 1,2,3,5, 8,10,15 Hz | 1,2,3,5, 8,10Hz | 810,755nm: 0.5~3 Hz (HR), 5~10 Hz(SHR); 2 Hz(LB)<br>1064nm: 0.5~3 Hz (HR), 5~10 (SHR)<br>Trio:40-800ms,Up to 10Hz. | | Wavelength | 755nm/810nm/1064nm for option | | | | 755nm/810nm/1064nm | {10}------------------------------------------------ | gth | | and three in one for<br>option | |-------------------------|-----------------------|--------------------------------| | Operation<br>interface | LCD color Touchscreen | LCD color Touchscreen | | Laser<br>classification | Class IV | Class IV | | Software | Yes | Yes | The indication of proposed device is covered by the predicated device. The proposed device is only intended to use for hair removal. The device includes seven models for clearance in this submission. The differences between models are the treatment area, laser energy density, pulse frequency, pulse width. These are covered by the predicated device. The different wavelengths (755nm/810nm/1064nm) are available for all models. The proposed device does not have NIR Modules or Trio Diode Laser modules (combining wavelengths) compared to the predicate device. The minor differences in indication do not alter the use of the proposed device. # VII Non-Clinical Testing A battery of tests has been performed to verify that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards: # Electrical safety and electromagnetic compatibility IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements IEC 60601-2-22:2007(third edition)+A1:2012 for use in conjunction with IEC 60601-1:2005 (third edition)+A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment ### Biocompatibility The patient contact component of the device was performed the Biocompatibility {11}------------------------------------------------ testing and reference standards as following testing: - Cytotoxicity . ISO 10993-5:2009, Biocompatibility Evaluation of Medical Device - Part 5: Tests for In Vitro Cytotoxicity - Sensitization ISO 10993-10:2010, ● Biocompatibility Evaluation of Medical Device - Part 10: Tests for Irritation and Shin Sensitization. - . Irritation ISO 10993-10:2010, Biocompatibility Evaluation of Medical Device - Part 10: Tests for Irritation and Shin Sensitization. # VIII Clinical Testing It is not applicable. # IX Conclusion The performance testing and software validation testing determined that the subject device is substantially equivalent to the predicate device.