Greenlight Moxy Fiber Optic
510(k) K120870
Greenlight Moxy Fiber Optic 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) K120870 on 15 Jun 2012, 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 | NumberK120870 | Date15 Jun 2012 | StatusActive |
Official records
- FDA 510(k) database K120870
Recalls
-
- Terminated Z-1798-2020
To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints.
Timeline
- Cleared FDA 510(k) K120870
- Recall initiated FDA recalls Z-1798-2020
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- Withdrawn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
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