Identity
- Trade Name
- SideLaze 3D Fiber w/RFID, 1000um, 10 pack FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- SideLaze 3D Fiber w/RFID, 1000um, 10 pack FDA UDI
- Model / Reference
- 807-5001-616 FDA UDI
- Description
- SideLaze 3D Fiber w/RFID, 1000um, 10 pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841494100404 FDA UDI
- 510(k) Number
- K141511 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical frequency-doubled 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
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
Ethylene Oxide FDA UDI
Category: General/multiple surgical frequency-doubled solid-state laser system
SideLaze 3D Fiber w/RFID, 1000um, 10 pack by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K141511 also covers:
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
- Cynosure, LLC
Sources (1)
- FDA UDI c18bd9ee-c047-4c29-bc23-afd96da532ff 34 fields · synced Jun 8, 2026