Adverl Evo Er: Yag Laser for Dentistry Mey-1-a
K120377 is the FDA 510(k) clearance record for ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A, a class II device, cleared for J. Morita USA, 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 52 510(k) clearances for J. Morita USA, Inc., from to . As of , FDA records show no recalls naming K120377.
Clearance record
- Decision date
- Received
- (170 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
- J. Morita USA, Inc. 1425 K St., NW, Suite 1100, Washington DC
- 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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