Identity
- Trade Name
- Diode Handpiece Assembly FDA UDI
- Generic Name
- Dermatological laser beam producing handpiece FDA UDI
- Device Name
- Handpiece Assembly FDA UDI
- Model / Reference
- 7122-00-2050 FDA UDI
- Description
- Handpiece Assembly FDA UDI
Identifiers
- Catalog Number
- 7122-00-2050 FDA UDI
- Primary DI / UDI-DI
- 00817495021911 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
- 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
Diode Handpiece Assembly 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Candela Corporation
Sources (1)
- FDA UDI 006074de-cf00-4c95-bdd5-002d70f20873 36 fields · synced Jun 8, 2026