Myriadlase Sidefire-Tipped Optical Fiber
K920553 is the FDA 510(k) clearance record for MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER, a class II device, cleared for Myriad Lase, 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 4 510(k) clearances for Myriad Lase, Inc., from to . As of , FDA records show no recalls naming K920553.
Clearance record
- Decision date
- Received
- (49 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
- Myriad Lase, Inc. 4800 SE Loop 820, Forest Hill TX
- 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 |
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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.
