Usdl Model Select 1000 Frequency Doubled Nd:yag Laser System
K943638 is the FDA 510(k) clearance record for USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM, a class II device, cleared for United States Dental Laser, 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 one 510(k) clearance for United States Dental Laser, Inc. As of , FDA records show no recalls naming K943638.
Clearance record
- Decision date
- Received
- (222 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
- United States Dental Laser, Inc. P.O. Box 6796, Hilton Head Island SC
- 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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