Fiber One
510(k) K100746
Fiber One is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by American Medical Systems, cleared under FDA 510(k) K100746 on 11 Jun 2010, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100746 | Date11 Jun 2010 | StatusActive |
Official records
- FDA 510(k) database K100746
Recalls
-
- Terminated Z-0834-2011
Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing
Timeline
- Cleared FDA 510(k) K100746
- Recall initiated FDA recalls Z-0834-2011
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- Withdrawn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
Similar devices
Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).
- ZenPro 40 by BLUECORE COMPANY Co., Ltd.
- DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) by El.En Electronic Engineering Spa
- FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS by Fotona D.D.
- CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL. by Heraeus Lasersonics, Inc.
- MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USE by Laser Engineering Heart, Inc.
- ENDOSCOPIC USES OF THE ARGON LASER IN GENERAL SURG by Hgm Medical Laser Systems, Inc.
- TRIO Handpiece by OMNIGUIDE, INC.
- PROLITE PULSED LIGHT SYSTEM by Big Sky Laser Technologies, Inc.
- SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER by SIRONA Dental Systems GmbH
- ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU by Bio Quantum Technologies, Inc.