(120 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware components and light therapy, with no mention of software algorithms or data processing that would indicate AI/ML.
Yes
The device is intended for "treating face wrinkles," which is a medical condition, making it a therapeutic device.
No
Explanation: The Intended Use/Indications for Use states that the device is intended for the use in treating face wrinkles. There is no mention of diagnosis in the provided text.
No
The device description explicitly states it is a "handheld laser device" composed of physical components like laser diodes, LEDs, lenses, a casing, and a rechargeable battery, indicating it is a hardware device, not software-only.
Based on the provided information, the LYMA Laser PRO is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "treating face wrinkles" using light therapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The device uses lasers and LEDs to deliver light to the skin. This is consistent with a therapeutic device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The LYMA Laser PRO's function is to directly treat a condition (wrinkles) on the body.
N/A
Intended Use / Indications for Use
The LYMA Laser PRO is an Over-the-Counter (OTC) light based device intended for the use in treating face wrinkles.
Product codes
OHS
Device Description
The LYMA Laser PRO is a compact, handheld laser device intended to provide low-level laser light therapy (LLLT) for the treatment of wrinkles. The LYMA Laser PRO system is composed of a handheld casing enclosing three low-level, 808nm laser diodes, and three red light-emitting diodes (LED). The device also includes one white LED that inform the user about device status during operation, and optical lenses that diffuse the laser light across a larger treatment window. The LYMA Laser PRO includes a rechargeable battery and is provided with a power cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Full face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
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 following tests were performed to demonstrate safety based on current industry standards:
Biocompatibility: Biocompatibility assessment was conducted per ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Electrical, Mechanical, and Thermal Safety: The subject device was tested and shown to conform with the following safety and performance standards:
- IEC 60601-1:2005/AMD1:2012/AMD2:2020 Medical electrical equipment Part 1: -General requirements for basic safety and essential performance
- -IEC 60601-1-6:2010/AMD1:2013/AMD:2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- -IEC 60601-1-11:2015/AMD1:2020 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
- -IEC 60601-2-22:2019 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Laser Safety: The subject device was tested and shown to conform with IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
Electromagnetic Compatibility: The subject device was tested and shown to conform with IEC 60601-1-2:2014/AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
Clinical testing was not necessary to demonstrate substantial equivalence.
Based on the testing performed, including electrical, EMC, and laser safety testing, and biocompatibility evaluation, it can be concluded that the subject device does not raise different questions of safety or effectiveness compared to the predicate devices. The identical indications for use and materials and the similar technological characteristics and performance characteristics for the proposed LYMA Laser PRO are assessed to be substantially equivalent to the predicate devices.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 21, 2025
LYMA Life Ltd. % Lucie Dalet Principal Consultant Ram+ 2790 Mosside Boulevard Suite 800 Monroeville, Pennsylvania 15146
Re: K243330
Trade/Device Name: LYMA Laser PRO 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 Dated: October 23, 2024 Received: October 24, 2024
Dear Lucie Dalet:
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 (the 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.
1
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.
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 820.70) 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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
2
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE -○ Date: 2025.02.21
13:58:41 -05'00'
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) K243330
Device Name LYMA Laser PRO
Indications for Use (Describe)
The LYMA Laser PRO is an Over-the-Counter (OTC) light based device intended for the use in treating face wrinkles.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
L Y M A
510(k) SUMMARY
DATE PREPARED
February 18, 2025
MANUFACTURER AND 510(k) OWNER
LYMA Life Ltd. 2nd Floor Edison House, 223-231 Old Marylebone Road, London, United Kingdom Telephone: Official Contact: Lucy Goff, Founder
REPRESENTATIVE/CONSULTANT
Lucie Dalet, Ph.D. Dulciana Chan, MSE Allison Komiyama, Ph.D., RAC RQM+ Telephone: +1 (412) 816-8253 Email: ldalet@rqmplus.com, dchan@rqmplus.com, akomiyama@rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | LYMA Laser PRO |
|---|---|
| Common Name: | Light Based Over The Counter Wrinkle Reduction |
| Regulation Number: | 21 CFR 878.4810 |
| Class: | II |
| Product Code: | OHS |
| Premarket Review: | OHT4 / DHT4A – General Surgery Devices |
| Review Panel: | General & Plastic Surgery |
PREDICATE DEVICE IDENTIFICATION
The LYMA Laser PRO is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary
Predicate |
|---------------|-----------------------------------------------------------------------------------|----------------------|
| K210823 | LYMA Laser / LYMA Life Ltd. | ✓ |
| K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023) / Light
Tree Ventures Europe B.V. | |
The predicate devices have not been subject to a design related recall.
DEVICE DESCRIPTION
The LYMA Laser PRO is a compact, handheld laser device intended to provide low-level laser light therapy (LLLT) for the treatment of wrinkles. The LYMA Laser PRO system is composed of a handheld casing enclosing three low-level, 808nm laser diodes, and three red light-emitting diodes (LED). The device also includes one white LED that inform the user about device status during operation, and optical lenses that diffuse the laser light across a larger treatment window.
5
The LYMA Laser PRO includes a rechargeable battery and is provided with a power cable.
INDICATIONS FOR USE
The LYMA Laser PRO is an Over-the-Counter (OTC) light based device intended for the use in treating face wrinkles.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Subject Device | Primary Predicate Device | Secondary Predicate Device | |
|---|---|---|---|
| LYMA Life, Ltd. | LYMA Life, Ltd. | Light Tree Ventures Europe | |
| B.V. | |||
| LYMA Laser PRO | |||
| K243330 | LYMA Laser | ||
| K210823 | Q-Rejuvalight Pro Facewear | ||
| K230042 | |||
| Indications for | |||
| Use | The LYMA Laser PRO is an | ||
| Over-the-Counter (OTC) light | |||
| based device intended for the use | |||
| in treating face wrinkles. | The LYMA Laser is an Over- | ||
| the-Counter (OTC) light based | |||
| device intended for the use in | |||
| treating full-face wrinkles. | The Q-Rejuvalight Pro Facewear | ||
| (Model: P19-0023) is an Over- | |||
| the-Counter (OTC) device | |||
| intended for treatment of | |||
| wrinkles and mild to moderate | |||
| inflammatory acne. | |||
| Product Code / | |||
| Regulation | OHS / 21 CFR 878.4810 | OHS / 21 CFR 878.4810 | OHS, OLP / 21 CFR 878.4810 |
| Regulation | |||
| Description | Laser surgical instrument for use | ||
| in general and plastic surgery | |||
| and in dermatology | Same | Same | |
| Anatomical Sites | Full face | Same | Same |
| Environment of | |||
| Use | OTC | Same | Same |
| Energy source | Laser diodes, LEDs | Same | LEDs |
| Laser Class | Class 3R | Class 1 | N/A |
| Wavelength | Laser diodes: 808 nm ± 2 nm | ||
| Red LEDs: 620 nm | Same | Wrinkles: 605nm, 630nm, | |
| 660nm, and 880nm | |||
| Acne: 415nm and 630nm | |||
| Output Mode | Continuous | Same | N/A |
| Treatment area | 20.4 cm2 | 8.55 cm2 | For wrinkles: 140 cm2 |
| Treatment Dose | 12.8 J/cm2 | 11.3 J/cm2 | 12.6 J/cm2 |
| Radiant Power | 1400 mW | 500 mW | Unknown |
| Irradiance | 71 mW/cm2 | 62.5 mW/cm2 | Total for wrinkles: 70 mW/cm2 |
| Power supply | 3.6 V/ 5000 mA rechargeable Li- | ||
| ion battery (non-removable) | 3.6V / 3500 mA rechargeable Li- | ||
| ion battery (removable) | 5V, 50/60Hz, 2A Li-ion Polymer | ||
| Battery: 3.7V, 600mAh, 2.22Wh | |||
| Treatment | |||
| regimen | 3 minutes per treatment area, | ||
| every day for 8 weeks | |||
| After 8 weeks, 3 minutes per | |||
| treatment area, 3 times per week. | Same | 3 minutes per treatment |
The subject device has the same intended use and Indications for Use statement as the primary predicate device. The LYMA Laser PRO uses a similar design and identical materials as the device cleared in K210823. Both the subject and primary predicate devices are handheld devices using laser diodes to output infrared light at a wavelength of 808 ± 2 nm. The subject device is
6
L Y M A
able to treat a larger area at a higher irradiance level than the primary predicate device. However, the output irradiance is similar to the secondary predicate device cleared in K230042. The technological differences do not raise new types of questions of safety and effectiveness. The different technological characteristics of the subject device have undergone testing to ensure the device is as safe and effective as the predicates.
SUMMARY OF NON-CLINICAL TESTING
The following tests were performed to demonstrate safety based on current industry standards:
Biocompatibility: Biocompatibility assessment was conducted per ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Electrical, Mechanical, and Thermal Safety: The subject device was tested and shown to conform with the following safety and performance standards:
- IEC 60601-1:2005/AMD1:2012/AMD2:2020 Medical electrical equipment Part 1: -General requirements for basic safety and essential performance
- -IEC 60601-1-6:2010/AMD1:2013/AMD:2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- -IEC 60601-1-11:2015/AMD1:2020 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
- -IEC 60601-2-22:2019 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Laser Safety: The subject device was tested and shown to conform with IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
Electromagnetic Compatibility: The subject device was tested and shown to conform with IEC 60601-1-2:2014/AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
SUMMARY OF CLINICAL TESTING
Clinical testing was not necessary to demonstrate substantial equivalence.
CONCLUSION
Based on the testing performed, including electrical, EMC, and laser safety testing, and biocompatibility evaluation, it can be concluded that the subject device does not raise different questions of safety or effectiveness compared to the predicate devices. The identical indications for use and materials and the similar technological characteristics and performance characteristics for the proposed LYMA Laser PRO are assessed to be substantially equivalent to the predicate devices.