Advatx
510(k) K132976
Advatx is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Advalight Aps, cleared under FDA 510(k) K132976 on 17 Apr 2014, 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 | NumberK132976 | Date17 Apr 2014 | StatusActive |
Official records
- FDA 510(k) database K132976
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K132976
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ADVATx 1.0 | 684 / 1.0 | 05700002052209 | — | On the market |
Similar devices
Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).
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