Identity
- Trade Name
- Glidesafe Handpiece FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- GLIDESAFE HP VARI-PAK 10MM,15MM&20MM-INT FDA UDI
- Model / Reference
- P2VPHPD FDA UDI
- Description
- GLIDESAFE HP VARI-PAK 10MM,15MM&20MM-INT FDA UDI
Identifiers
- Catalog Number
- P2VPHPD FDA UDI
- Primary DI / UDI-DI
- 00841494105075 FDA UDI
- 510(k) Number
- K102698 FDA UDI
- FDA Product Code
- GEI 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrosurgical system
Glidesafe 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
K102698 also covers:
- 10mm GlideSafe HP (3) and Cable — Cynosure, LLC
- 15mm GlideSafe HP (3) and Cable — Cynosure, LLC
- 20mm GlideSafe HP (3) and Cable — Cynosure, LLC
- 7.5mm GlideSafe HP (3) and Cable — Cynosure, LLC
- GlideSafe Handpiece Cord — Cynosure, LLC
- PV GLIDESAFE HP — Cynosure, LLC
- PV GLIDESAFE HP — Cynosure, LLC
- PV GLIDESAFE HP — Cynosure, LLC
- PV GLIDESAFE HP & CABLE 10MM INTL (3 HP) — Cynosure, LLC
- Pelleve GlideSafe 10MM HP, 1PC — Cynosure, LLC
- Pelleve GlideSafe 15MM HP, 1PC — Cynosure, LLC
- Pelleve GlideSafe 20MM HP, 1PC — 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 fad3961e-ad01-4fa8-9ba6-0a319b06b4fd 35 fields · synced Jun 8, 2026