Panels › General, Plastic Surgery › Product code ONG · Class 2
Powered Laser Surgical Instrument With MicrobeamFractional Output
Regulation 878.4810
0510(k)s in 12 months (35 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in ONG
| Company | 510(k)s | Recalls |
|---|---|---|
| AVAVA, Inc. | 5 | 0 |
| Solta Medical, Inc. | 3 | 2 |
| Palomar Medical Products, Inc. | 3 | 0 |
| Ids, Ltd. | 1 | 1 |
| Lutronic Corporation | 2 | 0 |
| Palomar Medical Technologies, Inc. | 2 | 0 |
| Shanghai Apolo Medical Technology Co., Ltd. | 2 | 0 |
| Tria Beauty, Inc. | 2 | 0 |
| Wingderm Electro-Optics , Ltd. | 1 | 1 |
| Beijing Sincoheren Science and Technology Development Co. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2025 | IDS LTD Smaxel Fractional CO2 Laser, a Class IV medical laser system. Open, Classified |
ONG | K180036 |
| Dec 5, 2024 | WINGDERM ELECTRO-OPTICS LTD. Non-ablative Fractional Laser Systems, Model: WFB-01 Open, Classified |
ONG | K192350 |
| Apr 16, 2014 | Solta Medical, Inc. FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures. Terminated |
ONG | K101490 |
| Feb 1, 2011 | Solta Medical, Inc. Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology.
Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500 Terminated |
ONG | K091420 K101490 |
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