Identity
- Trade Name
- Large Spot Specialty Delivery System Assembly FDA UDI
- Generic Name
- Dermatological laser beam guiding handpiece FDA UDI
- Device Name
- Speciality Delivery System Assembly FDA UDI
- Model / Reference
- 7122-00-9760 FDA UDI
- Description
- Speciality Delivery System Assembly FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817495021195 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological laser beam guiding 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 guiding handpiece
Large Spot Specialty Delivery System Assembly by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K140122 also covers:
- GentleMax Delivery System — Candela Corporation
- GentleMax Pro — Candela Corporation
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- GentleMax Pro — Candela Corporation
- GentleYAG — Candela Corporation
- GentleYAG — Candela Corporation
- GentleYAG — Candela Corporation
- GentleYAG — Candela Corporation
- GentleYAG — Candela Corporation
- GentleYAG — Candela Corporation
- GentleYAG 1.5/3MM Delivery System W/DCD — Candela Corporation
K140732 also covers:
- Fiber Cable Assembly — Candela Corporation
- 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
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 7c82f82e-1cc7-48b7-8dfb-7762c21901d9 34 fields · synced Jun 8, 2026