Identity
- Trade Name
- Profound, SubQ Single- Use Cartridge, Packaged FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- Profound, SubQ Single- Use Cartridge, Packaged FDA UDI
- Model / Reference
- AS87913 FDA UDI
- Description
- Profound, SubQ Single- Use Cartridge, Packaged FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817495024370 FDA UDI
- 510(k) Number
- K161043 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-modality skin surface treatment system
Profound, SubQ Single- Use Cartridge, Packaged by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multi-modality skin surface treatment system.
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Cleared under the same submission
K161043 also covers:
- Dermal Single- Use Cartridge 6-Pkg, Profound, — Candela Corporation
- Dermal applicator — Candela Corporation
- Profound System, Packaged — Candela Corporation
- Profound, Dermal Single- Use Cartridge, Packaged — Candela Corporation
- SubQ Single- Use Cartridge 6-Pkg, Profound — Candela Corporation
- SubQ applicator — 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 652138ed-ec5d-42ef-8f02-9858373049ab 34 fields · synced Jun 8, 2026