Identity
- Trade Name
- BVLASER FDA UDI
- Generic Name
- Intense pulsed light skin surface treatment system FDA UDI
- Device Name
- The Intense Pulsed Light Treatment System (Model: LK-PT) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. FDA UDI
- Model / Reference
- LK-PT FDA UDI
- Description
- The Intense Pulsed Light Treatment System (Model: LK-PT) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974851083014 FDA UDI
- 510(k) Number
- K242440 FDA UDI
- FDA Product Code
- ONF FDA UDI
- GMDN Term
- Intense pulsed light skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intense pulsed light skin surface treatment system
Bvlaser by Nanjing Bestview Laser S&T Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nanjing Bestview Laser S&T Co., Ltd.
Sources (1)
- FDA UDI 1d7ed88f-a815-4b9d-9f25-f69239489294 34 fields · synced Jun 9, 2026