Lucid Q-PTP / HWA 55
K161670 is the FDA 510(k) clearance record for Lucid Q-PTP / HWA 55, a class II device, cleared for Bison Medical Co, Ltd. 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 3 510(k) clearances for Bison Medical Co, Ltd., from to . As of , FDA records show no recalls naming K161670.
Clearance record
- Decision date
- Received
- (139 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
- Bison Medical Co, Ltd. Ace High-End Tower 6, 1801 Beotkkot-Ro, Gasan Dong, Guem Chen Gu, KR
- 510(k) summary
- Summary PDF
- 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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