(130 days)
No
The device description focuses on the hardware (LEDs, power supply, touch screen) and its function (emitting light at specific wavelengths). There is no mention of AI, ML, image processing, or any data analysis capabilities that would suggest the use of such technologies. The control system is described as using pre-set and customizable protocols based on energy or time, not on adaptive or learning algorithms.
Yes
The device is indicated for treating dermatological conditions, muscle and joint pain, arthritis, and promoting relaxation and increased blood circulation, all of which fall under therapeutic uses.
No
The device description explicitly states: "The Dermalux systems are not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat." This indicates it is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical hardware components including a main body, power supply, touch screen control panel, adjustable treatment head with LEDs, and an articulating arm mechanism. While it has software for control, it is fundamentally a hardware device that emits light.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The indications for use describe treating dermatological conditions (acne, lesions) and providing temporary relief for muscle and joint pain. These are all direct treatments applied to the body, not tests performed on samples taken from the body.
- Device Description: The device description details a system that emits light for therapeutic purposes. It does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The description explicitly states the device is "not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat." This is a key characteristic of IVD devices, which are designed to provide diagnostic information.
In summary, the device is a therapeutic light-emitting device used for direct treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Indications for use include:
· The blue light (415nm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
· The red light (633nm wavelength) 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, ILY
Device Description
The Dermalux Tri-Wave MD MK II & Dermalux Compact MD is a Medical Device (MDR Class II) which emits specific wavelengths of low level, narrow band light for the treatment of certain aesthetic, dermatological and medical indications. The wavelengths used in the Tri-Wave MD MK II & Compact MD systems are Blue 415nm, Red 633nm and Near Infrared 830nm. The Dermalux professional use family consists of the Tri-Wave MD MKI; a floor standing unit with 4 pod treatment head, Compact MD; desk mounted unit with a 3 pod treatment head.
The system enables treatment of the body via an articulated 4 or 3 panel LED head. The panels can be easily adjusted for focused intensity treatments and application to larger body areas.
The system consists of a main body that contains the power supply (100-240Vac, 50/60Hz), power switch, touch screen control panel and a 4 or 3 panel adjustable treatment head that contains Light Emitting Diodes (LEDs).
The power supply is designed to power the internal electronics for the system and the Light Emitting Diodes. The power supply is connected to a suitable mains outlet. The device is switch located below the screen in the base unit.
The Tri-Wave MD MK II & Compact MD system is operated by a full colour capacitive touch screen which features pre-set and post treatment protocols that can be customised with three power settings. Bespoke protocols can be programmed based on delivered energy or time. The device cannot be networked or connect to the internet, software updates can be performed via a USB flash drive (thumb drive) if required.
The light is generated by Light Emitting Diodes (LED's) which a treatment head. The treatment head is connected to the main body by articulating arm mechanism. The arm allows the operator to correctly position the LED head ment area.
Protective eye wear is supplied with each Dermalux unit for patient and operator comfort.
The Dermalux systems are not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent.
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The conclusions drawn from the noncinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo 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 square and the full name written out in a sans-serif font below it. The Department of Health and Human Services logo is a stylized human figure.
June 4, 2024
Aesthetic Technology Ltd Martin Hodgson Head of Regulaton Unit 211 Europa Boulevard Warrington, Cheshire WA5 7TN United Kingdom
Re: K240222
Trade/Device Name: Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) 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, ILY Dated: April 23, 2024 Received: April 23, 2024
Dear Martin Hodgson:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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.
Digitally signed by
Tanisha L. Hithe -S Tanisha L. Date: 2024.06.04 Hithe -S 17:25:56 -04'00'
Tanisha Hithe 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
3
Indications for Use
510(k) Number (if known) K240222
Device Name
-
Dermalux Tri-Wave MD MKII
-
Dermalux Compact MD
Indications for Use (Describe)
Indications for use include:
· The blue light (415nm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
· The red light (633nm wavelength) 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary # K240222
Prepared on: 2024-05-23
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| Applicant Name | Aesthetic Technology Ltd |
| Applicant Address | Unit 211 Europa Boulevard Warrington Cheshire WA5 7TN United Kingdom |
| Applicant Contact Telephone | +44 (0) 1925 396721 |
| Applicant Contact | Mr. Martin Hodgson |
| Applicant Contact Email | martin.h@dermaluxled.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| Device Trade Name | Dermalux Tri-Wave MD MKII (1000021); |
| Dermalux Compact MD (1000024); | |
| Common Name | Laser surgical instrument for use in general and plastic surgery and in dermatology |
| Classification Name | Powered Laser Surgical Instrument |
| Regulation Number | 878.4810 |
| Product Code | GEX, ILY |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product |
|---|---|---|
| Code K200659 | Dermalux Tri-Wave MD | GEX |
Device Description Summary
The Dermalux Tri-Wave MD MK II & Dermalux Compact MD is a Medical Device (MDR Class II) which emits specific wavelengths of low level, narrow band light for the treatment of certain aesthetic, dermatological and medical indications. The wavelengths used in the Tri-Wave MD MK II & Compact MD systems are Blue 415nm, Red 633nm and Near Infrared 830nm. The Dermalux professional use family consists of the Tri-Wave MD MKI; a floor standing unit with 4 pod treatment head, Compact MD; desk mounted unit with a 3 pod treatment head.
The system enables treatment of the body via an articulated 4 or 3 panel LED head. The panels can be easily adjusted for focused intensity treatments and application to larger body areas.
The system consists of a main body that contains the power supply (100-240Vac, 50/60Hz), power switch, touch screen control panel and a 4 or 3 panel adjustable treatment head that contains Light Emitting Diodes (LEDs).
The power supply is designed to power the internal electronics for the system and the Light Emitting Diodes. The power supply is connected to a suitable mains outlet. The device is switch located below the screen in the base unit.
The Tri-Wave MD MK II & Compact MD system is operated by a full colour capacitive touch screen which features pre-set and post treatment protocols that can be customised with three power settings. Bespoke protocols can be programmed based on delivered energy or time. The device cannot be networked or connect to the internet, software updates can be performed via a USB flash drive (thumb drive) if required.
21 CFR 807.92(a)(4)
5
The light is generated by Light Emitting Diodes (LED's) which a treatment head. The treatment head is connected to the main body by articulating arm mechanism. The arm allows the operator to correctly position the LED head ment area.
Protective eye wear is supplied with each Dermalux unit for patient and operator comfort.
The Dermalux systems are not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent.
Intended Use/Indications for Use
The blue spectrum light (415nm) is intended to treat moderate inflammatory acne vulgaris.
The red spectrum light (633nm) is generally indicated for treatment of superficial, benign, vascular and pigmented lesions.
The near-infrared light (830nm) is generally indicated 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 where applied.
Indications for Use Comparison
All devices described in this document have the same indications as those listed in the above section "Intended Use/ Indications for Use" and therefore Aesthetic Technology Ltd consider the Dermalux Tri-Wave MD MKI, and the Dermalux Compact MD to be equivalent to the Dermalux Tri-Wave MD (K200659) for purposes of Section 510(k) of the Federal Food, drug and Cosmetic Act.
Technological Comparison
Each of the Dermalux devices (Dermalux Tri-Wave MD MKI) & Dernalux Compact MD) whether three panels have the same technological characteristicans for use as the Dermalux Tri-Wave MD placed in commercial distribution by Aesthetic Technology Ltd. on May 9, 2020 pursuant to 510(k) premarket notification K200659 and are therefore considered to be substantially equivalent to the Dermalux Tri-Wave MD.
The use of the blue, red and NIR regions of the spectrum are to emit energy to treat the following conditions:
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 (830m 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
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The conclusions drawn from the noncinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section.
21 CFR 807.92(a)(5)