Dermalux Tri-Wave MD

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Aesthetic Technology Ltd. % Richard Hamer US Agent Richard Hamer Associates LLC 705 Spring Lakes Blvd Bradenton, Florida 34210 Re: K200659 Trade/Device Name: Dermalux Tri-Wave MD 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 9, 2020 Received: March 12, 2020 Dear Richard Hamer: 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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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, Colin Kejing Chen, Ph.D. 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) K200659 Device Name Derrmalux® Tri-Wave MD #### Indications for Use (Describe) The Derrmalux® Tri-Wave MD 's use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The red light (633nm wavelength) is generally indicated for treatment of superficial, benign, vascular and pigmented lesions. The near-infrared light (830nm wavelength) is generally indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 16px;"> <span style="font-family: DejaVu Sans, sans-serif;"> <span style="color: black;">☑</span> </span> </span> | | Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 16px;"> <span style="font-family: DejaVu Sans, sans-serif;"> <span style="color: black;">☐</span> </span> </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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ADMINISTRATIVE #### Submitter: Aesthetic Technology Ltd. 211 Europa Blvd. Warrington, Cheshire WA5 7TN United Kingdom +44 (0) 845 689 1789 Contact Person: Dale Needham Date of Preparation: May 6, 2020 ### II. DEVICE NAME Proprietarv Name: Dermalux® Tri-Wave MD Common Name: Powered Laser Surgical Instrument Classification Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulation Number: 21 CFR §878.4810 Regulatory Class: Class II Product Code: GEX ### III. PREDICATE DEVICE Phototherapy System; K190938; Shanghai Apolo Medical Technology Co, Ltd. ### IV. DEVICE DECRIPTION The Dermalux® Tri-Wave MD is a floor standing Class II medical device which emits specific wavelengths of low level, narrow band light for the treatment of dermatological conditions. The wavelengths used in the Tri-Wave MD system are Blue 415nm, Red 633nm and Near Infrared 830nm. The device consists of a main body that contains the power supply, power switch, touch screen control panel, and a 4 panel adjustable treatment head that contains Light Emitting Diodes ena {4}------------------------------------------------ bling treatment of the face and the body. The panels can be easily adjusted for focused intensity treatments and application to larger body areas. ## V. INDICATIONS FOR USE The Dermalux® Tri-Wave MD's use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The red light (633nm wavelength) is generally indicated for treatment of superficial, benign, vascular and pigmented lesions. The near infrared light (830nm wavelength) is generally indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied. | Parameter | Subject Device | Predicate Device (K190938) | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product name | Dermalux® Tri-Wave MD | Photodynamic Therapy System (HS-770) | | Product code | GEX | GEX | | Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | | Class | Class II | Class II | | Intended use | Use of the red, blue and near-infrared regions of the spectrum to emit energy to treat dermatological conditions | Use of the red, blue and infrared regions of the spectrum to emit energy to treat dermatological conditions. | | Indications for use | Blue light (415nm wavelength): Treatment of dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.<br>Red light (633nm wavelength: Treatment of superficial, benign, vascular and pigmented lesions.<br>NIR (830nm wavelength): Temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied. | The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.<br>The red light (630nm wavelength) is generally indicated for treatment of superficial, benign vascular and pigmented lesions.<br>The infrared light (835nm wavelength) is generally used for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied. | | Parameter | Subject Device | Predicate Device (K190938) | | Power supply | 100-240Vac, 50/60Hz, 4.6 -1.85A, 460-<br>430W. | AC 100-240V 50/60Hz 10A | | Wavelength | Red light: 633nm±5nm<br>Blue light: 415nm±5nm<br>NIR light: 830nm±5nm | Red light: 630nm±15nm<br>Blue light: 415nm±15nm<br>IR light: 835nm±15nm | | Panels Type | 4 Panels | 3 Panel: 180 EA LEDs 4 Panel: 240 EA LEDs The panels may emit the three lights (red, blue, infrared) individually or in combination | | Light frequency | N/A as DC Power | 200 Hz | | Output Power | Red - 633nm (105mW/cm2)<br>Blue - 415nm (40mW/cm2)<br>NIR - 830nm (55mW/cm2) | Each LED lamp bead has 4 diodes that emit different colors; the energy power of a diode is 3W. | | Maximum power<br>density in mW | Red: 105mW/cm2<br>Blue: 40mW/cm2<br>NIR: 55mW/cm2 | Red light: 115mW/cm2<br>Blue light: 120mW/cm2<br>IR: 70mW/cm2<br>Red/IR: 120mW/cm2<br>Blue/IR: 150mW/cm2 | | Standard dose in<br>Joules | Red: 126J/cm2<br>Blue: 48J/cm2<br>NIR: 66J/cm2 | Red: 138J/cm2<br>Blue: 144J/cm2<br>IR: 84J/cm2<br>Red/IR: 144J/cm2<br>Blue/IR: 180J/cm2 | | Adjustable dose<br>range | Red: 1-126J/cm2<br>Blue: 1-48J/cm2<br>NIR: 1-66J/cm2<br>Red/IR: 1-192J/cm2<br>Blue/IR: 1-114J/cm2<br>Blue/Red: 1-174J/cm2 | Red: 1-242J/cm2<br>Blue: 1-180J/cm2<br>IR:1-147J/cm2<br>Red/IR: 1-144J/cm2<br>Blue/IR:1-180J/cm2 | | Treatment area | 792cm2 | 756cm2 and 1008cm2 | | Treatment time | Up to 20 minutes | 20 minutes (recommended treatment time) | | Numbers of LEDs | 120 LED's per color, per panel. Total of<br>480 LED's per color per unit. 1440<br>LED's in total. | 3 panels: 180EA<br>4 panels: 240EA | | Working distance | 2.5cm minimum distance from source | 10~15cm | | Operation interface | Display Screen | Display Screen | | Dimension | 1400mm[H]×500mm[W]×700mm[D] | 500mm[H]×500mm[W]×1350mm[D] | | Safety<br>classification | Class I | Class I | | Software | Yes | Yes | ## VI. COMPARISON TO PREDICATE DEVICE {5}------------------------------------------------ ## VII. PERFORMANCE TESTING Bench: Performance testing of the Dermalux® Tri-Wave MD was conducted to verify that the device met all design specifications. The test results demonstrate that the Dermalux® Tri-Wave MD complies with all requirements, including international and FDA-recognized consensus standards: {6}------------------------------------------------ EN/IEC 60601-1 (FDA #19-4) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance: 2005 EN/IEC 60601-1-2 (FDA #19-8) Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests: 2018 EN/IEC 62304 (FDA #13-79) Medical device software - Software life cycle processes: 2006 EN/IEC 62471 (FDA #12-249) Photobiological safety of lamps and lamp systems: 2008 IEC 60601-2-57 (FDA #12-242) Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use: 2011 IEC 62366-1 (FDA #5-113) Medical devices - Part 1: Application of usability engineering to medical devices: 2015 EN/IEC 60601-1-6 (FDA #5-89) Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability: 2013 Photometric Testing of LED Light Panel Animal: No studies were performed. Clinical: No studies were performed. ### VIII. CONCLUSION Based on design considerations and testing of product attributes, we conclude that the Dermalux® Tri-Wave MD performs at least as well as the predicate device. The Dermalux® Tri-Wave MD is therefore considered to be substantially equivalent to the above-mentioned predicate device.