(58 days)
Not Found
No
The summary describes a light-emitting device for dermatological treatment and pain relief. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device description or performance studies.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to emit energy to treat dermatological conditions" and lists several specific conditions it aims to treat, such as moderate inflammatory acne vulgaris, superficial/benign/vascular/pigmented lesions, and temporary relief of minor muscle/joint pain. These uses clearly fall under the definition of a therapeutic device.
No
The document describes the Dermalux® Tri-Wave MD as a device intended to emit energy to treat dermatological conditions and provide temporary relief for pain, stiffness, and muscle spasms. It does not mention any function related to diagnosing conditions.
No
The device description clearly outlines physical hardware components including a main body, power supply, power switch, touch screen control panel, and a 4-panel adjustable treatment head containing Light Emitting Diodes.
Based on the provided information, the Dermalux® Tri-Wave MD is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "emit energy to treat dermatological conditions" and for therapeutic purposes like pain relief and increasing blood circulation. IVDs are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a light-emitting device applied to the body, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with IVD devices.
Therefore, the Dermalux® Tri-Wave MD is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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:
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
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. 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.
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
1
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 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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
510(k) Summarv
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: 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
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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. | |
| Red light (633nm wavelength: Treatment of superficial, benign, vascular and pigmented lesions. | ||
| 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. | |
| The red light (630nm wavelength) is generally indicated for treatment of superficial, benign vascular and pigmented lesions. | ||
| 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- | |
| 430W. | AC 100-240V 50/60Hz 10A | |
| Wavelength | Red light: 633nm±5nm | |
| Blue light: 415nm±5nm | ||
| NIR light: 830nm±5nm | Red light: 630nm±15nm | |
| Blue light: 415nm±15nm | ||
| 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) | |
| Blue - 415nm (40mW/cm2) | ||
| 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 | ||
| density in mW | Red: 105mW/cm2 | |
| Blue: 40mW/cm2 | ||
| NIR: 55mW/cm2 | Red light: 115mW/cm2 | |
| Blue light: 120mW/cm2 | ||
| IR: 70mW/cm2 | ||
| Red/IR: 120mW/cm2 | ||
| Blue/IR: 150mW/cm2 | ||
| Standard dose in | ||
| Joules | Red: 126J/cm2 | |
| Blue: 48J/cm2 | ||
| NIR: 66J/cm2 | Red: 138J/cm2 | |
| Blue: 144J/cm2 | ||
| IR: 84J/cm2 | ||
| Red/IR: 144J/cm2 | ||
| Blue/IR: 180J/cm2 | ||
| Adjustable dose | ||
| range | Red: 1-126J/cm2 | |
| Blue: 1-48J/cm2 | ||
| NIR: 1-66J/cm2 | ||
| Red/IR: 1-192J/cm2 | ||
| Blue/IR: 1-114J/cm2 | ||
| Blue/Red: 1-174J/cm2 | Red: 1-242J/cm2 | |
| Blue: 1-180J/cm2 | ||
| IR:1-147J/cm2 | ||
| Red/IR: 1-144J/cm2 | ||
| 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 | |
| 480 LED's per color per unit. 1440 | ||
| LED's in total. | 3 panels: 180EA | |
| 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 | ||
| classification | Class I | Class I |
| Software | Yes | Yes |
VI. COMPARISON TO PREDICATE DEVICE
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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.