Vbeam Prima Laser System
510(k) K183452
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK183452 | Date1 Feb 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Vbeam Prima Laser System is a Pulsed-Dye Laser (PDL) Device (595 nm) with integrated Nd:YAG Laser (1064 nm), designed for the treatment of vascular and pigmented lesions. It delivers controlled laser energy to target blood vessels, melanin, and other chromophores in skin and soft tissue, facilitating selective photothermolysis for cosmetic and dermatological applications.
This system is supplied as a medical device and is intended for use in clinical settings by trained professionals. It is non-sterile and reusable, with specifications tailored for vascular and pigmented lesion treatments on the face, neck, and body. Authorized under FDA 510(k) clearance (K183452), it adheres to regulatory standards for Special 510(k) review in the General, Plastic Surgery advisory category.