IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240969 FDA 510(k)
- FDA Product Code
- OHT 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 is a light-based over-the-counter hair removal device intended for removal of unwanted body and/or facial hair. It uses Intense Pulsed Light (IPL) technology via Xenon flashlamp to deliver optical radiation pulses for hair reduction.
The device is designed for home use with manual activation via finger switch and includes a skin sensor that detects contact to enable light pulse emission. It is supplied as a personal light-based hair reduction device and has received FDA 510(k) clearance under K240969 with product code OHT and regulation number 878.4810.
Frequently asked questions
What is the IPL Hair Removal device intended for?
The IPL Hair Removal device is intended for removal of unwanted body and/or facial hair. It uses Intense Pulsed Light (IPL) technology via Xenon flashlamp to deliver optical radiation pulses for hair reduction, designed specifically for home use.
How is the IPL Hair Removal device operated?
The device is designed for home use with manual activation via finger switch. It includes a skin sensor that detects contact to enable light pulse emission, ensuring safe operation when properly positioned on the skin.
What regulatory clearance has the IPL Hair Removal device received?
The device has received FDA 510(k) clearance under K240969 with product code OHT and regulation number 878.4810. This clearance indicates it has been determined to be substantially equivalent to predicate devices for hair reduction.
What models are included in the IPL Hair Removal device line?
The IPL Hair Removal device line includes four models: SL-B287, SL-B329, SL-B301-1, and SL-B328. All models share the same intended use and technology for hair reduction at home.
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. Sources consulted: IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328) (K240969) — FDA ..., IPL Hair Removal (SL-B287, SL-B329, SL-B301-1… - FDA.report, IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240969 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Semlamp Intelligent Technology Co., Ltd.
Sources (1)
- FDA 510(k) K240969 24 fields · synced Oct 6, 2026