Arthroscopic Lumbar Mechanical and Laser Discectom
K913566 is the FDA 510(k) clearance record for ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM, a class II device, cleared for Alfred O. Bonati, M.D. on under FDA product code GEX (Powered Laser Surgical Instrument). FDA's definition for product code GEX reads: "A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue...". FDA records list one 510(k) clearance for Alfred O. Bonati, M.D. As of , FDA records show no recalls naming K913566.
Clearance record
- Decision date
- Received
- (620 days to decision)
- Product code
- GEX Powered Laser Surgical Instrument
- Regulation
- 21 CFR 878.4810
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Applicant
- Alfred O. Bonati, M.D. 7315 Hudson Ave., Hudson FL
- 510(k) summary
- Statement
- Third party review
- No
Clearances, product code GEX
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 11 |
| December 2025 | 5 |
| January 2026 | 4 |
| February 2026 | 6 |
| March 2026 | 7 |
| April 2026 | 5 |
| May 2026 | 8 |
| June 2026 | 3 |
| July 2026 | 4 |
| August 2026 | 4 |
| September 2026 | 11 |
| October 2026 | 0 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
