Identity
- Trade Name
- VBeam Prima Laser System, JP FDA UDI
- Generic Name
- Dermatological dye laser system FDA UDI
- Device Name
- Pulsed Laser FDA UDI
- Model / Reference
- 9914-KK-9080 FDA UDI
- Description
- Pulsed Laser FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817495023274 FDA UDI
- 510(k) Number
- K230990 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological dye laser 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatological dye laser system
VBeam Prima Laser System, JP by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological dye laser system.
- Handpiece tip, reusable — Cynosure, LLC · Class II
- Apolomed — Shanghai Apolo Medical Technology Co., Ltd · Class II
- Apolomed — Shanghai Apolo Medical Technology Co., Ltd · Class II
- Vbeam Platinum — Candela Corporation · Class II
- Vbeam Aesthetica — Candela Corporation · Class II
- Vbeam Aesthetica — Candela Corporation · Class II
- Vbeam Perfecta — Candela Corporation · Class II
- Vbeam Aesthetica — Candela Corporation · Class II
Cleared under the same submission
K230990 also covers:
- ASSY, DELIVERY SYS, DCD HP, PRIMA REFURBISHED — Candela Corporation
- Perfecta Delivery System, Refurbished — Candela Corporation
- Vbeam 5MM Delivery System W/O DCD — Candela Corporation
- Vbeam 7MM Delivery System W/O DCD — Candela Corporation
- Vbeam Aesthetica — Candela Corporation
- Vbeam Aesthetica — Candela Corporation
- Vbeam Aesthetica — Candela Corporation
- Vbeam Aesthetica Delivery System — Candela Corporation
- Vbeam Aesthetica Distance Gauge Kit — Candela Corporation
- Vbeam Perfecta — Candela Corporation
- Vbeam Perfecta — Candela Corporation
- Vbeam Perfecta — Candela Corporation
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Candela Corporation
Sources (1)
- FDA UDI 8b452c61-7238-468f-9165-f74e8b1ef300 34 fields · synced Jun 8, 2026