(121 days)
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 treatment of periorbital and full face wrinkles.
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 wavelengths. 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.
The provided document is a 510(k) summary for the Dermalux Flex MD device. It describes the device, its intended use, and its comparison to predicate devices to demonstrate substantial equivalence. However, this document does NOT contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device, which is what your request is asking for.
The Dermalux Flex MD is a light therapy device, not an AI/ML-driven diagnostic or therapeutic device. The performance testing mentioned is entirely bench testing for electrical safety, electromagnetic compatibility, software lifecycle, photobiological safety, and usability of the hardware. There are no animal or clinical studies performed or referenced for the Dermalux Flex MD in this document, let alone studies involving AI/ML performance, ground truth establishment, or human reader effectiveness.
Therefore, I cannot extract the information you requested about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
To answer your request, a different type of FDA submission document, typically a De Novo application or a more extensive 510(k) for an AI/ML device, would be required. Those documents would detail the clinical validation studies, including the metrics, ground truth, and statistical analyses relevant to AI/ML performance.
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November 18, 2021
Aesthetic Technology Ltd. % Richard Hamer US Agent/Consultant Richard Hamer Associates, LLC 705 Spring Lakes Blvd Bradenton, Florida 34210
Re: K212275
Trade/Device Name: Dermalux Flex 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: OHS, OLP, ILY Dated: October 19, 2021 Received: October 25, 2021
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); 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 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.
Purva Pandya 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
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Indications for Use
510(k) Number (if known) K212275
Device Name
Dermalux Flex MD
Indications for Use (Describe)
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 treatment of periorbital and full face wrinkles.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K212275
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: November 18, 2021
II. DEVICE NAME
Proprietary Name: Dermalux® Flex MD
Common Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology
Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over-The Counter Wrinkle Reduction (OHS) and Lamp Infrared, Therapeutic Heating (ILY),
Regulation Number: 21 CFR §878.4810
Regulatory Class: Class II
Product Code: OLP, OHS, ILY
III. PREDICATE DEVICES
Dermalux® Flex MD; K202028, Aesthetic Technology Ltd.
Flexible LED Light Therapy Model HK209; K200983, Guangzhou GLOOMED Biological Technology Co. Ltd.
In addition, Omnilux CLEAR; K210948, GlobalMed Technologies and Biophotas Celluma3; K152280, Biophotas, Inc. are cited as reference devices for the purpose of establishing labeling equivalence.
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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 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 wavelengths. 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.
V. INDICATIONS FOR USE
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 use in dermatology for the treatment of periorbital and full face wrinkles.
| Parameter | Subject Device | Predicate Device (K202028) | Secondary Predicate (K200983) |
|---|---|---|---|
| Product name | Dermalux® Flex MDPhototherapy System | Dermalux® Flex MDPhototherapy System | Flexible LED Light TherapyModel HK209 |
| Product code | OHS, OLP. ILY | ILY, OHS, OLP | OHS, OLP, ILY |
| Regulation No. | 21 CFR 878.481021 CFR 890.5500 | 21 CFR 878.481021 CFR 890.5500 | 21 CFR 878.481021 CFR 890.5500 |
| Class | Class II | Class II | Class II |
| Intended use | Use of the red, blue and near-infrared regions of the spectrumto emit energy to treat dermato-logical and musculoskeletalconditions. | Use of the red, blue and near-infrared regions of the spectrumto emit energy to treat dermato-logical and musculoskeletalconditions | Use of the red, blue and near-infrared regions of the spectrumto emit energy to treat dermato-logical and musculoskeletal con-ditions |
| Indications for use | Intended to deliver heat in the IRspectrum to provide topicalheating for the purpose of ele-vating tissue temperature; for thetemporary relief of minor muscleand joint pain, arthritis andmuscle spasm; relieving stiff- | Intended to deliver heat in the IRspectrum to provide topicalheating for the purpose of ele-vating tissue temperature; for thetemporary relief of minor muscleand joint pain, arthritis andmuscle spasm; relieving stiff- | The device emitting energy in theblue spectrum is intended to re-duce mild to moderate inflamma-tory acne vulgaris.The device emitting energy in thered and infrared spectrum is in-tended for the treatment of full- |
VI. COMPARISON TO PREDICATE DEVICES
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| ness; 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. | ness; 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. | face wrinkles. The device 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 joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation | |
|---|---|---|---|
| Power supply | 100-240Vac, 50/60Hz, 4.6 - 1.85A, 460-430W. | 100-240Vac, 50/60Hz, 4.6 - 1.85A, 460-430W. | 100-240 Vac2.0 A, 50/60Hz |
| Wavelength | Red light: 633nm±5nmBlue light: 415nm±5nmNIR light: 830nm±5nm | Red light: 633nm±5nmBlue light: 415nm±5nmNIR light: 830nm±5nm | Red light: 640nmBlue light: 465nmNIR Light: 880nm |
| Panels Type | 1 Panel | 1 Panel | 1 Panel |
| Light frequency | 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) | Red - 633nm (11.5mW/cm²)Blue - 415nm (5.52mW/cm²)NIR - 830nm (5.5mW/cm² | 6.5 mW/cm² |
| Standard dose in Joules | Red: 20J/cm²Blue: 10J/cm²NIR: 10J/cm² | Red: 20J/cm²Blue: 10J/cm²NIR: 10J/cm² | 11.7 J/cm² |
| Treatment area | Face and Body792 cm² | Face and Body792 cm² | Face and Body890 cm² |
| Treatment time | Up to 30 minutes | Up to 30 minutes | 30 minutes |
| Treatment protocol(Treatment time) | Acne and Wrinkles: 3-4x weekly; 4 wks. Pain relief: 3x weekly | Not stated | 3x weekly; 4wks |
| Operation interface | Device uses a pre-set timer and software to control treatment duration. | Device uses a pre-set timer and software to control treatment duration. | Not stated |
| Software | Yes | Yes | Not stated |
Substantial equivalence is readily evidenced by comparison of product attributes summarized in the table above. Apparent differences in output power and standard dose do not impact safety or 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:
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
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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.
VIII. CONCLUSION
The Dermalux Flex MD is technologically identical to the predicate device cleared under K202028, intended for over-the-counter use, and similar to secondary predicate device K200983. Labeling is equivalent to reference devices K210948 and K152280. Based on design considerations and testing of product attributes, we conclude that the Dermalux® Flex MD performs at least as well as the predicate devices. The Dermalux® Flex MD is therefore considered to be substantially equivalent to the above-mentioned predicate devices.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.