Cooper Laser Sonics Nd: Yag Laser, Model 8008
K853117 is the FDA 510(k) clearance record for COOPER LASER SONICS ND: YAG LASER, MODEL 8008, a class II device, cleared for Cooper Lasersonics, 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 54 510(k) clearances for Cooper Lasersonics, Inc., from to . As of , FDA records show no recalls naming K853117.
Clearance record
- Decision date
- Received
- (383 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
- Cooper Lasersonics, Inc. 3420 Central Expy. ., Santa Clara CA
- 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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