Ipl Hair Removal (Model: SL-B080, SL-B126, SL-B136)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221246 FDA 510(k)
- FDA Product Code
- OHT FDA 510(k)
- Models / Variants
- Model: SL-B080 FDA 510(k)SL-B126 FDA 510(k)SL-B136 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ipl Hair Removal device is a light based over-the-counter hair removal device. It is classified as a General and Plastic Surgery device. The device has models Sl-B080, Sl-B126, and Sl-B136.
The device is supplied with various registration numbers and is regulated under regulation number 878.4810. It has been cleared with a Traditional clearance type and has an FDA 510K authorization. The device is used for hair removal and is classified as a class 2 device.
Frequently asked questions
What is the IPL Hair Removal device used for?
The IPL Hair Removal device is used for hair removal, and is classified as a class 2 device, regulated under regulation number 878.4810.
What models are available for the IPL Hair Removal device?
The IPL Hair Removal device has models SL-B080, SL-B126, and SL-B136.
Is the IPL Hair Removal device cleared by the FDA?
Yes, the IPL Hair Removal device has been cleared with a Traditional clearance type and has an FDA 510K authorization, indicating it is substantially equivalent to a predicate device.
What type of clearance does the IPL Hair Removal device have?
The IPL Hair Removal device has a Traditional clearance type, which means it was reviewed and cleared by the FDA through the 510K process.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221246 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Semlamp Intelligent Technology Co., Ltd.
Sources (1)
- FDA 510(k) K221246 24 fields · synced Sep 21, 2026