Identity
- Trade Name
- MaxY Handpiece, Remanufactured FDA UDI
- Generic Name
- Light-energy skin surface treatment system applicator FDA UDI
- Device Name
- MaxY Handpiece, Remanufactured FDA UDI
- Model / Reference
- 2520B-Y026R FDA UDI
- Description
- MaxY Handpiece, Remanufactured FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841494107611 FDA UDI
- 510(k) Number
- K110907 FDA UDI
- FDA Product Code
- GEX FDA UDIONG FDA UDI
- GMDN Term
- Light-energy skin surface treatment system applicator 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: Light-energy skin surface treatment system applicator
MaxY Handpiece, Remanufactured by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Light-energy skin surface treatment system applicator.
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- HR690XL applicator — Venus Concept Inc. · Class II
Cleared under the same submission
K110907 also covers:
- 1064+ Handpiece — Cynosure, LLC
- 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
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 8457ae8f-ac73-4025-a6a1-b7415bee5798 34 fields · synced Jun 8, 2026