Identity
- Trade Name
- 1064+ Handpiece FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- 1064+ Handpiece FDA UDI
- Model / Reference
- 2520A-1064P FDA UDI
- Description
- 1064+ Handpiece FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841494100261 FDA UDI
- 510(k) Number
- K110907 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
1064+ Handpiece by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K110907 also covers:
- 1064+ Handpiece — Cynosure, LLC
- 1540 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 |
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Manufacturer
- Manufacturer
- Cynosure, LLC
Sources (1)
- FDA UDI 07b6ad62-e77d-4659-8b67-1ecc9f9a086e 34 fields · synced Jun 1, 2026