Identity
- Trade Name
- FlexSure Large Applicator 10-Pack FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- FlexSure Large Applicator 10-Pack FDA UDI
- Model / Reference
- ASY-14112 FDA UDI
- Description
- FlexSure Large Applicator 10-Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841494108540 FDA UDI
- 510(k) Number
- K200241 FDA UDI
- FDA Product Code
- PBX FDA UDIGEI FDA UDI
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical system
FlexSure Large Applicator 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
K200241 also covers:
- ASSY, 60MM Body Accessory Kit, TempSure — Cynosure, LLC
- ASSY, Full Body Kit With 60mm Kit — Cynosure, LLC
- ASSY, Handpiece, 60mm, TempSure — Cynosure, LLC
- ASSY, Head, Massage, Cellulite, 60mm, TempSure — Cynosure, LLC
- FlexSure Interface Adapter — Cynosure, LLC
- FlexSure Large Applicator — Cynosure, LLC
- FlexSure Medium Applicator — Cynosure, LLC
- FlexSure Medium Applicator 10-Pack — 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 d4f51f39-0842-40a5-8726-3b9e4282d431 34 fields · synced May 30, 2026