Identity
- Trade Name
- Vbeam Prima Pro DCD Handpiece FDA UDI
- Generic Name
- Dermatological laser beam producing handpiece FDA UDI
- Device Name
- ASSY, DCD HP, DELIVERY SYSTEM, VBEAM PRIMA PRO FDA UDI
- Model / Reference
- 7123-00-0836 FDA UDI
- Description
- ASSY, DCD HP, DELIVERY SYSTEM, VBEAM PRIMA PRO FDA UDI
Identifiers
- Catalog Number
- 7123-00-0836 FDA UDI
- Primary DI / UDI-DI
- 00817495025247 FDA UDI
- 510(k) Number
- K230990 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological laser beam producing handpiece 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 laser beam producing handpiece
Vbeam Prima Pro DCD Handpiece by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological laser beam producing handpiece.
- LightSheer® Duet ET™ Handpiece — Lumenis Be, Inc. · Class II
- LightSheer® Duet HS™ Handpiece — Lumenis Be, Inc. · Class II
- PURE Laser, EPL810 HP — ENDYMED MEDICAL LTD · Class II
- Vbeam Aesthetica Delivery System — Candela Corporation · Class II
- Vbeam Aesthetica Distance Gauge Kit — Candela Corporation · Class II
- ASSY, DCD HAND PIECE, LARGE SPOT, GMPP — Candela Corporation · Class II
- FSE, PicoWay 785nm Handpiece — Candela Corporation · Class II
- GMPP ACC Large Spot Option Kit, w/HP, w/SAs, w/Fiber Assembly — 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 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Candela Corporation
Sources (1)
- FDA UDI 6d782d2c-7016-4f04-98f1-73983e9019e1 35 fields · synced Jun 8, 2026