Azuryt Model Clt 1401, CO2 Surgical Laser System
K042439 is the FDA 510(k) clearance record for AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM, a class II device, cleared for Diamond Age Systems, 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 Diamond Age Systems, Inc. As of , FDA records show no recalls naming K042439.
Clearance record
- Decision date
- Received
- (28 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
- Diamond Age Systems, Inc. 3775 S. Laurel Way, Chandler AZ
- 510(k) summary
- Summary PDF
- Third party review
- Yes
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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