Identity
- Trade Name
- Fiber Cable Assembly FDA UDI
- Generic Name
- Dermatological solid-state laser system FDA UDI
- Device Name
- Fiber Assembly FDA UDI
- Model / Reference
- 7120-00-9380 FDA UDI
- Description
- Fiber Assembly FDA UDI
Identifiers
- Catalog Number
- 7120-00-9380 FDA UDI
- Primary DI / UDI-DI
- 00817495022451 FDA UDI
- 510(k) Number
- K140732 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological solid-state 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 solid-state laser system
Fiber Cable Assembly by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dermatological solid-state laser system.
- CLARITY II — Lutronic Corporation · Class II
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- EPY-50 — DDC TECHNOLOGIES, INC. · Class II
- HYPERION Gold Handpiece — Laseroptek Co., Ltd · Class II
- Thunder HR — Quanta System Spa · Class II
- CLARITY II — Lutronic Corporation · Class II
Cleared under the same submission
K140732 also covers:
- Fiber Cable Assembly — Candela Corporation
- Fiber Cable Assembly — Candela Corporation
- GL 12MM Fiber Assembly — Candela Corporation
- GLP 12/15/18MM Fiber Assembly — Candela Corporation
- GentleLASE Pro — Candela Corporation
- GentleLASE Pro-U — Candela Corporation
- GentleLASE Pro-U — Candela Corporation
- GentleLASE Pro-U — Candela Corporation
- GentleLase 12/15/18MM RGD Delivery System W/DCD — Candela Corporation
- GentleLase 6/8/10MM RGD Delivery System W/DCD — Candela Corporation
- GentleLase 6/8/10MM RGD Delivery System W/O Fiber — Candela Corporation
- GentleLase Delivery System W/O DCD — 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 f86918fa-cf5e-4d19-9a78-055294e17d54 35 fields · synced Jun 8, 2026