Device Information
The Epilaser Pro uses laser energy at 808 or 980nm wavelengths to target and disable hair follicles. It features a skin tone sensor to ensure appropriate skin compatibility before activation and includes an automatic hair-targeting algorithm for precise treatment. The handheld, noninvasive device has a spot size, peak power, fluence, and pulse duration similar to its predicate devices. Epilaser Pro comes into two varieties, Brunette and Dark, which differ in regard to the wavelength of light they emit and the skin tones they can treat (I-IV or V-VI, respectively).
Indications
The Epilaser Pro is intended for adjunctive use with shaving for sustained hair removal through periodic treatments. It is also used for a permanent reduction in hair regrowth, as defined by a stable reduction in the number of regrowing hairs measured 6, 9, and 12 months after the treatment regimen is completed.
Intended Use
The device is designed for over-the-counter hair removal and permanent reduction in hair regrowth. It is suitable for anyone seeking sustained hair reduction through non-invasive laser treatment and is compatible with different skin tones, as verified by its skin tone sensor.
Availability
The device is available over-the-counter and does not require a prescription.
Contraindications
No specific contraindications mentioned in the 510k document.
Limitations
The device is designed for external use only and should not be applied on damaged or tattooed skin without professional consultation. Additionally, it may not be suitable for all skin tones and requires built-in skin tone sensor verification.
Study Results
Clinical testing of the device showed a high safety profile and efficacy. In safety evaluations involving 44 subjects, only mild and transient side effects like erythema and blistering were observed and resolved within 48 hours. The efficacy study involving 69 subjects of varying skin tones showed that the device achieved over 90% accuracy in targeting hair follicles without damaging pigmented or tattooed regions.
The Epilaser Pro underwent extensive safety testing to ensure its biocompatibility, electromagnetic compatibility, and laser safety. This includes biocompatibility testing per ISO 10993-1, software validation according to FDA guidelines, and electrical and EMC testing per AAMI/EN 60601-1 and 60601-1-2. Additional laser safety protocols followed IEC 60601-2-22 and IEC 60825-1, with photobiological safety assessed via IEC 62471 and household appliance safety tested per IEC 60335-2-23.
Regulatory Information
- Regulation Number: 21 CFR 878.4810
- Regulatory Class: Class II
- Product Code: GEX
- 510(k) Number: K233224
The Epilaser Pro must adhere to 21 CFR 878.4810, which regulates laser surgical instruments used in general surgery, plastic surgery, and dermatology. It is classified as a Class II device. It must also comply with 21 CFR Part 820, the Quality System (QS) Regulation, which covers design controls, nonconforming products, and corrective actions. Additionally, it is subject to 21 CFR Parts 807 for registration and listing, 801 for labeling requirements, and 803 for medical device reporting of adverse events.
Manufacturer Information
- Manufacturer Name: Epilady 2000 LLC
- Address: 3 Hacharash St., Industrial Zone, Hazor Haglilit, Israel 1035102
- Contact: Moshe Rosenthal
Predicate Device Information
- Predicate Device: Epilaser K170970 and Epilaser Absolute K213105
- Is the predicate device an earlier version of the same device? Yes
- Differences between the predicate device and the current device: The Epilaser Pro has an automatic hair-targeting algorithm and an updated user interface. It performs better detecting hairs and avoiding pigmented regions than manual operation in the predicate device.
Implications
The Epilaser Pro presents a user-friendly option for over-the-counter hair removal, offering improved efficacy and safety through advanced targeting algorithms.
References
- Epilaser Pro. 510(k) Number. K233224. FDA Summary Link. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K233224
- https://www.epilady.com/
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