Davol Endo-Flo Laser Probe and Accessories
K920659 is the FDA 510(k) clearance record for DAVOL ENDO-FLO LASER PROBE AND ACCESSORIES, a class II device, cleared for Davol, Inc. 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 32 510(k) clearances for Davol, Inc., from to . As of , FDA records show no recalls naming K920659.
Clearance record
- Decision date
- Received
- (114 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
- Davol, Inc. 100 Sockanossett Crossroad, Cranston RI
- 510(k) summary
- Summary
- 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 |
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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
