Intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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.

The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris.

Intended to emit energy in the red and infrared spectrum for the use in dermatology for the treatment of periorbital and full face wrinkles.

Device Description

The Dermalux® Flex MD is a Class II medical device for use on a treatment bed. The device emits specific wavelengths of low level, narrow band light for the treatment of certain dermatological and musculoskeletal indications. The wavelengths used in the Dermalux® Flex MD system are Blue 415nm, Red 633nm and Near Infrared 830nm.

The Dermalux® Flex MD enables treatment of the face and the body via a flexible LED Array. The system is operated by a capacitive touch Controller, which allows one of 3 treatments to be selected, through selecting various wavelength combinations. The light is generated by Light Emitting Diodes (LED's) that are contained within the flexible LED Array. The LED Array can be placed into the Base, holding in the appropriate position to administer a facial treatment. For use on the body, the LED Array is removed from the Base unit and placed over the appropriate body part.

AI/ML Overview

The Dermalux Flex MD device does not have explicit acceptance criteria or a study proving that it meets specific clinical or performance acceptance criteria in the provided text. The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to predicate devices, rather than proving efficacy against acceptance criteria through clinical trials.

The "Performance Testing" section (Page 6) details bench testing to verify that the device met design specifications and complied with various international and FDA-recognized consensus standards related to electrical safety, electromagnetic compatibility, software lifecycle, photobiological safety, usability, and biological evaluation. These are related to the safety and fundamental functioning of the device, not clinical efficacy or specific performance metrics for the indicated uses.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present clinical acceptance criteria for efficacy in terms of specific performance metrics (like percentage reduction in acne or wrinkles) for the Dermalux Flex MD. Instead, it demonstrates compliance with safety and engineering standards. The table below lists the performance testing conducted, which can be seen as meeting "design specifications" and regulatory consensus standards, rather than clinical acceptance criteria.

Acceptance Criteria (related to Safety & Engineering Standards)	Reported Device Performance (Compliance Shown)
EN/IEC 60601-1 (General requirements for basic safety and essential performance)	Complies
EN/IEC 60601-1-2 (Electromagnetic disturbances)	Complies
EN/IEC 60601-1-11 (Home healthcare environment)	Complies
EN/IEC 62304 (Medical device software life cycle processes)	Complies
EN/IEC 62471 (Photobiological safety)	Complies
IEC 60601-2-57 (Non-laser light source equipment)	Complies
IEC 62366-1 (Usability engineering to medical devices)	Complies
EN/IEC 60601-1-6 (Usability)	Complies
Photometric Testing of LED Light Panel	Meets design specifications
ISO 10993-1 (Biological evaluation of medical devices)	Complies

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable for clinical efficacy studies. The testing was bench-based for engineering and safety standards.
Data Provenance: Not applicable for clinical studies as no clinical studies were performed. The "data" refers to engineering test results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as no clinical ground truth was established; testing was focused on engineering and safety standards.

4. Adjudication method for the test set

Not applicable as no clinical ground truth was established or adjudicated; testing was focused on engineering and safety standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was performed as this device is a light therapy device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable as this device is a light therapy device, not an algorithm.

7. The type of ground truth used

Not applicable for clinical efficacy. The "ground truth" for the performance testing refers to the established technical specifications of the device and the requirements of the international and FDA-recognized consensus standards.

8. The sample size for the training set

Not applicable as no clinical training set was used. The focus was on engineering and safety testing.

9. How the ground truth for the training set was established

Not applicable as no clinical training set was used.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

December 16, 2020

Aesthetic Technology Ltd % Richard Hamer US Agent/Consultant Richard Hamer Associates LLC 705 Spring Lakes Blvd Bradenton, Florida 34210

Re: K202028

Trade/Device Name: Dermalux Flex MD Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY, OLP, OHS Dated: November 19, 2020 Received: November 23, 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. 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.

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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 and Part 809); 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 (OS) 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.

Purva Pandya 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

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Indications for Use

510(k) Number (if known) K202028

Device Name

Dermalux Flex MD

Indications for Use (Describe)

The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris.

Intended to emit energy in the red and infrared spectrum for the use in dermatology for the treatment of periorbital and full face wrinkles.

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)

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510(k) SUMMARY

I. 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: December 11, 2020

II. DEVICE NAME

Proprietary Name: Dermalux® Flex MD

Common Name: Infrared Lamp; Powered Light Based Non-Laser Surgical Instrument

Classification Name: Infrared Lamp; Laser surgical instrument for use in general and plastic surgery and in dermatology

Regulation Number: 21 CFR §878.4810 and §890.5500

Regulatory Class: Class II

Product Code: ILY, OLP, OHS

III. PREDICATE DEVICES

Biophotas Celluma 3 Phototherapy System: K152280 and K171323, Biophotas Inc .; Rejuvalite MD; K133896, Trophy Skin Inc. and Opera Lebody; K201107, GTG Wellness Co. Ltd.

IV. DEVICE DECRIPTION

The Dermalux® Flex MD is a Class II medical device for use on a treatment bed. The device emits specific wavelengths of low level, narrow band light for the treatment of certain

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dermatological and musculoskeletal indications. The wavelengths used in the Dermalux® Flex MD system are Blue 415nm, Red 633nm and Near Infrared 830nm.

V. INDICATIONS FOR USE

The Dermalux Flex MD is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and ioint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris. The Dermalux Flex MD is intended to emit energy in the red and infrared spectrum for use in dermatology for the treatment of periorbital and full face wrinkles.

Parameter	Subject Device	Predicate Devices(K152280 and K171323)	Secondary PredicateK133896	Secondary PredicateK201107
Product name	Dermalux® Flex MDPhototherapy System	Biophotas Celluma3	Rejuvalite MD	Opera Lebody
Product code	ILY, OHS, OLP	ILY, OHS, OLP	OHS	OHS
Regulation No.	21 CFR 878.4810 and 21CFR 890.5500	21 CFR 878.4810 and 21CFR 890.5500	21 CFR 878.4810	21 CFR 878.4810
Class	Class II	Class II	Class II	Class II
Intended use	Use of the red, blue andnear-infrared regions ofthe spectrum to emitenergy to treatdermatological andmusculoskeletalconditions.	Use of the red, blue andnear-infrared regions ofthe spectrum to emitenergy to treatdermatological andmusculoskeletalconditions	Use of the red and near-infrared regions of thespectrum to emit energyto treat full face wrinkles	Use of the red and near-infrared regions of thespectrum to emit energyto treat full face wrinkles
Indications for use	Intended to deliver heat inthe IR spectrum toprovide topical heating forthe purpose of elevatingtissue temperature; for thetemporary relief of minormuscle and joint pain,arthritis and musclespasm; relieving stiffness;promoting the relaxation	The BioPhotas Celluma3is intended to deliver heatin the IR spectrum toprovide topical heating forthe purpose of elevatingtissue temperature; for thetemporary relief of minormuscle and joint pain,arthritis and musclespasm; relieving stiffness;	Intended for use in thetreatment of full facewrinkles	Intended for use in thetreatment of full facewrinkles

VI. COMPARISON TO PREDICATE DEVICES

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	of muscle tissue; and totemporarily increase localblood circulation.The blue spectrum light isintended to reduce mild tomoderate inflammatoryacne vulgaris.Intended to emit energy inthe red and infraredspectrum for the use indermatology for thetreatment of periorbitaland full face wrinkles.	promoting relaxation ofmuscle tissue; and totemporarily increase localblood circulation. Theblue spectrum is intendedto reduce mild tomoderate inflammatoryacne vulgaris. TheCelluma3 is intended toemit energy in the red andinfrared region of thespectrum for use indermatology for thetreatment of periorbital(K152280) and full face(K171323) wrinkles
Parameter	Subject Device	Predicate Devices(K152280 and K171323	Secondary PredicateK133896	Secondary PredicateK201107
Power supply	100-240Vac, 50/60Hz, 4.6-1.85A, 460-430W.	110 - 120V	110-120V	Not stated
Wavelength	Red light: 633nm±5nmBlue light: 415nm±5nmNIR light: 830nm±5nm	Red light: 640nm +/-25nmBlue light: 465nmNIR light: 880nm +/-50nm	Red Light: 600, 622,600nmNIR Light: 860nm	Red Light: 630 nmNIR Light: 830 nm
Panels Type	1 Panel	1 Panel	1 Panel	1 Panel (Mask)
Light frequency	N/A as DC Power	N/A as DC Power	N/A as DC Power	N/A as DC Power
Output Power	Red - 633nm(11.5mW/cm²)Blue - 415nm(5.52mW/cm²)NIR - 830nm(5.5mW/cm²)	6.5 mW/cm²	62 mW/cm² (at 4 "distance)	50 mW/cm²
Standard dose inJoules	Red: 20J/cm²Blue: 10J/cm²NIR: 10J/cm²	11.7 J/cm²	11.2 J/cm²	30J/cm²
Treatment area	792 cm²	773 cm²	90 cm²	Not stated
Treatment time	Up to 30 minutes	Up to 30 minutes	3 minutes	10 minutes
Operation interface	Device uses a pre-settimer and software tocontrol treatment duration.	Device uses a timer andsoftware to controltreatment duration.	Device uses a timer tocontrol treatment duration.	Device uses a timer tocontrol treatment duration.
Software	Yes	Yes	No	No
Use	OTC	OTC	OTC	OTC

Substantial equivalence is readily evidenced by comparison of product attributes summarized in above. Apparent differences in output power and standard dose do not impact safety and effectiveness because the amount of energy delivered to the skin is similar due to differences in treatment duration and distance from the LED source.

VII. PERFORMANCE TESTING

Bench: Performance testing of the Dermalux® Flex MD was conducted to verify that the device met all design specifications. The test results demonstrate that the Dermalux® Flex MD complies with all requirements, including international and FDA-recognized consensus standards:

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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 60601-1-11 (FDA #19-14) Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment: 2015

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

ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

Animal: No studies were performed.

Clinical: No studies were performed.

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VIII. CONCLUSION

Based on design considerations and testing of product attributes, we conclude that the Dermalux® Flex MD performs at least as well as the above-mentioned predicate devices. The Dermalux® Flex MD is therefore considered to be as safe, as effective, and to perform as well as the legally marketed predicate devices.

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.