Identity
- Trade Name
- Aerin Console Set FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- The Aerin Console Set consists of the following items: 1) Aerin Console unit, 2) Power Cord, 3) Foot Switch.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. FDA UDI
- Model / Reference
- CAT305 FDA UDI
- Description
- The Aerin Console Set consists of the following items: 1) Aerin Console unit, 2) Power Cord, 3) Foot Switch.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. FDA UDI
Identifiers
- Catalog Number
- CAT305-02 FDA UDI
- Primary DI / UDI-DI
- 08886479300047 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
MR Unsafe FDA UDI
Category: Electrosurgical system
Aerin Console Set by Aerin Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162810 also covers:
- Aerin Console — 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 (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
- Aerin Medical Inc.
Sources (1)
- FDA UDI 15d561d7-e5fb-4111-adc2-4a8e6180dd76 37 fields · synced Jun 6, 2026