Identity
- Trade Name
- Slimline 365 Fiber FDA UDI
- Generic Name
- General/multiple surgical solid-state laser system FDA UDI
- Model / Reference
- Slimline 365 Fiber FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109140018 FDA UDI
- 510(k) Number
- K140388 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General/multiple surgical solid-state laser system
Slimline 365 Fiber by Lumenis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K140388 also covers:
- Duotome Sidelite 550 Fiber — Lumenis
- SlimLine EZ 550 Fiber — Lumenis
- Slimline 1000 Fiber — Lumenis
- Slimline 200 Fiber — Lumenis
- Slimline 550 Fiber — Lumenis
- Slimline EZ 200 Fiber — Lumenis
- Slimline EZ 365 Fiber — Lumenis
- Slimline EZ 550 Fiber — Lumenis
- Slimline EZ SIS 200 Fiber — Lumenis
- Slimline EZ SIS 365 Fiber — Lumenis
- Slimline EZ SIS 550 Fiber — Lumenis
- Slimline Endo 200 Fiber — Lumenis
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
- Lumenis
Sources (1)
- FDA UDI 9154df8d-6655-43d2-9a0d-f73d5acff05f 34 fields · synced Jun 8, 2026