Identity
- Trade Name
- Aerin Console FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode. The Aerin Console Set consists of the following items: 1) Aerin Console unit, 2) Power Cord, 3) Foot Switch and is intended for use with one or more Aerin Styli. FDA UDI
- Model / Reference
- FG226 FDA UDI
- Description
- The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode. The Aerin Console Set consists of the following items: 1) Aerin Console unit, 2) Power Cord, 3) Foot Switch and is intended for use with one or more Aerin Styli. FDA UDI
Identifiers
- Catalog Number
- CAT305 FDA UDI
- Primary DI / UDI-DI
- 08886479300030 FDA UDI
- 510(k) Number
- K162810 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical system
Aerin Console by Aerin Medical Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K162810 also covers:
- Aerin Console Set — Aerin Medical Inc.
- Foot Switch — Aerin Medical Inc.
- InSeca ARC Stylus — Aerin Medical Inc.
- Power Cord — Aerin Medical Inc.
- Power Cord (OUS) — Aerin Medical Inc.
- Power Cord (OUS) 15 FT — Aerin Medical Inc.
- Power Cord (UK) — Aerin Medical Inc.
- Power Cord (UK) 15 FT — Aerin Medical Inc.
- Power Cord 15 ft (US) — Aerin Medical Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Aerin Medical Inc.
Sources (2)
- FDA UDI 49e8371f-7fbd-4ba5-955e-7e3d0ded3f77 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026