IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106,…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230097 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)
This device is a Light-Based Over-The-Counter Hair Removal Device, classified as a Class II medical device under FDA regulations. It employs Intense Pulsed Light (IPL) technology to target and reduce hair growth by selectively damaging hair follicles through controlled energy delivery to the skin’s surface. Suitable for general cosmetic hair reduction, it is designed for non-invasive, at-home or professional use on various body areas, including the face, legs, and underarms.
The device is supplied as a reusable, non-sterile system intended for single-user operation. Models BSXT101 through BSXT108 are MRI-safe and require no special storage conditions beyond a clean, dry environment. Authorized under FDA 510(k) clearance and MDD compliance, these models are categorized under product code OHT for over-the-counter hair removal. No sterilization or professional handling is required, though user instructions must be followed to ensure safe and effective operation.
Frequently asked questions
What body areas can this IPL hair removal device be safely used on according to its intended purpose?
This IPL device is designed for non-invasive, at-home or professional use on general cosmetic hair reduction areas, including the face, legs, and underarms. The manufacturer specifies it targets hair follicles through controlled energy delivery to the skin’s surface, making it suitable for these common regions where hair removal is sought.
Is this device reusable, and if so, how should it be maintained?
Yes, the IPL hair removal device is supplied as a reusable system intended for single-user operation. Since it is non-sterile, it does not require sterilization between uses. However, the manufacturer advises keeping it in a clean, dry environment to ensure safe and effective operation, following the included user instructions closely.
Are there any special storage requirements for this device, and can it be used in an MRI environment?
No special storage conditions are required beyond maintaining a clean, dry environment. The device is explicitly labeled as MRI-safe, meaning it can be used in an MRI environment without interference or risk.
What regulatory pathways has this device undergone, and what does that mean for its use?
This device has been authorized under both FDA 510(k) clearance and MDD compliance, confirming it meets regulatory standards for safety and effectiveness. The FDA classification as a Class II medical device and the product code OHT (Over-the-Counter Hair Removal) indicate it is intended for non-prescription use, though it remains subject to manufacturer guidelines for proper operation.
How many models are available, and are there differences between them?
Eight models are available: BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108. While the exact specifications for each model aren’t detailed here, they share the same core functionality (IPL hair removal) and regulatory compliance. Differences may lie in features like energy settings, handpiece design, or additional accessories, but all are reusable, non-sterile, and intended for single-user use.
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 (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230097 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen BSX Technology Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K230097 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026