Identity
- Trade Name
- Apyx® FDA UDI
- Generic Name
- Calibration gas cylinder regulator FDA UDI
- Device Name
- Apyx One Console Helium Gas Regulator, Digital FDA UDI
- Model / Reference
- APYX-HGSD FDA UDI
- Description
- Apyx One Console Helium Gas Regulator, Digital FDA UDI
Identifiers
- Catalog Number
- APYX-HGSD FDA UDI
- Primary DI / UDI-DI
- 00607151050276 FDA UDI
- 510(k) Number
- K221830 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Calibration gas cylinder regulator 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Calibration gas cylinder regulator
Apyx® by Apyx Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Calibration gas cylinder regulator.
- MicroAire® — MicroAire Surgical Instruments LLC · Class I
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- Bovie® — BOVIE MEDICAL CORPORATION · Class II
- Renuvion®/J-Plasma® — Apyx Medical Corporation · Class II
Cleared under the same submission
K221830 also covers:
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
- Apyx Medical Corporation
Sources (1)
- FDA UDI 4422f255-0484-41da-97bf-9b01de0c8a48 36 fields · synced Jun 9, 2026