Identity
- Trade Name
- 1540 handpiece FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- 1540 handpiece FDA UDI
- Model / Reference
- 2520C-1540 FDA UDI
- Description
- 1540 handpiece FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841494100247 FDA UDI
- FDA Product Code
- ONG FDA UDIGEX FDA UDI
- GMDN Term
- Multi-modality skin surface treatment 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: Multi-modality skin surface treatment system
1540 handpiece by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-modality skin surface treatment system.
- Deep2 — Termosalud · Class I
- Isolaz — Solta Medical, Inc. · Class II
- Handpiece 570 (6.4) for Harmony XL — ALMA LASERS LTD. · Class II
- Tip ClearLift QS KTP 532 4mm (Female) — ALMA LASERS LTD. · Class II
- ClearLift Depth Control Set for ClearLift QS 5x5 (No Lasing Tip) Female — ALMA LASERS LTD. · Class II
- OXYLIGHT — RAJA Medical · Class II
- Deep2 — Termosalud · Class I
- Harmony XL System Black 110V — ALMA LASERS LTD. · Class II
Cleared under the same submission
K090195 also covers:
K101506 also covers:
K110907 also covers:
- 1064+ Handpiece — Cynosure, LLC
- 1064+ Handpiece — Cynosure, LLC
- 1541 handpiece — Cynosure, LLC
- Max G Handpiece — Cynosure, LLC
- Max G Handpiece — Cynosure, LLC
- Max R Handpiece — Cynosure, LLC
- Max R Handpiece — Cynosure, LLC
- Max Rs Handpiece — Cynosure, LLC
- Max Rs Handpiece — Cynosure, LLC
- Max Ys Handpiece — Cynosure, LLC
- Max Ys Handpiece — Cynosure, LLC
- MaxY Handpiece — Cynosure, LLC
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 99350fde-9c2f-4943-80a1-4ef898969c79 34 fields · synced May 31, 2026