A3F Frational
by Pollogen Ltd
510(k) K122200
A3F Frational is a Class II device made by Pollogen Ltd, cleared under FDA 510(k) K122200 on 18 Apr 2013, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122200 | Date18 Apr 2013 | StatusActive |
Official records
- FDA 510(k) database K122200
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEI
- FDA applicant
- Pollogen, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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