Home › Device types › ONG
Powered Laser Surgical Instrument With MicrobeamFractional Output
FDA product code ONG · Class 2 · General, Plastic Surgery
210
Registered devices
151
Adverse events
4
Recalls
35
510(k) clearances
Devices with this code
Q-Switch Nd:YAG Metal Treatment Tip 2.5 mm — LUMENIS LTD.EXELO2 CO2 Laser System — ALMA LASERS LTD.Universal IPL Treatment Head — LUMENIS LTD.Max Ys Handpiece — Cynosure, LLCMulti-spot Nd:YAG SapphireCool Light Guide set — LUMENIS LTD.CLEAR+BRILLIANT TOUCH — SOLTA MEDICALQ-Switched Nd:YAG Treatment Head — LUMENIS LTD.ResurFX Precision Tip — LUMENIS LTD.Edge ONE — Jeisys Medical Inc.CYMA — BISON MEDICAL Co.,Ltd.LUX1540 Handpiece, REMANUFACTURED — Cynosure, LLCStellart M22 - ResurFX Upgrade — LUMENIS LTD.eCO2 3D — Cynosure Lutronic Technology CorporationMax Rs Handpiece — Cynosure, LLCSkin Renu Laser — Tria Laser IncFraxis 1.1 Main Unit — ILOODA.CO.,LTDUniversal IPL 515 nm Expert Filter — LUMENIS LTD.1064+ Handpiece — Cynosure, LLCeCO2 3D — Cynosure Lutronic Technology CorporationApolomed — Shanghai Apolo Medical Technology Co.,LtdSapphireCool Light Guide 8 × 15 mm — LUMENIS LTD.LUXR HP, StarLux 500 Repl — Cynosure, LLCOptiLight IPL Upgrade Kit — LUMENIS LTD.eCO2 3D — Cynosure Lutronic Technology Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-16 | IDS LTD | The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device. |
| 2024-08-23 | WINGDERM ELECTRO-OPTICS LTD. | Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labe |
| 2014-03-20 | Solta Medical, Inc. | Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment |
| 2010-12-15 | Solta Medical, Inc. | The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs. |
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