Total clearances
2
2023-03-29 → 2023-12-21
Name variants in FDA filings: Ids, Ltd. / Ids, Limited
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| GEX |
Powered Laser Surgical Instrument |
Class II |
General, Plastic Surgery |
2 |
2023-12-21 |
Safety
Recalls (1)
Class I (serious)
0
Risk of injury / death
| Date | Severity | Status | Recall # |
Product | Code | Reason |
| 2024-10-16 |
Class II
|
Ongoing |
Z-0804-2025 |
Smaxel Fractional CO2 Laser, a Class IV medical laser system. |
— |
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device. |
Filings
All 510(k) clearances (2)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2023-12-21 |
K233018 |
PICOSECOND Nd:YAG Laser System |
GEX |
Class II |
General, Plastic Surgery |
| 2023-03-29 |
K222485 |
SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser |
GEX |
Class II |
General, Plastic Surgery |