Identity
- Trade Name
- Vbeam FDA UDI
- Generic Name
- Dermatological dye laser system FDA UDI
- Device Name
- Pulsed Laser FDA UDI
- Model / Reference
- 9914-10-0723 FDA UDI
- Description
- Pulsed Laser FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08174950200307 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
- Not 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
Vbeam by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K230990 also covers:
- ASSY, DELIVERY SYS, DCD HP, PRIMA REFURBISHED — Candela Corporation
- Perfecta Delivery System, Refurbished — Candela Corporation
- VBeam Prima Laser System, JP — 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
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
- Candela Corporation
Sources (1)
- FDA UDI 662c3001-40d9-4989-8f68-6cec51340a63 37 fields · synced Jun 8, 2026