Home › Device types › ONG
Powered Laser Surgical Instrument With MicrobeamFractional Output
FDA product code ONG · Class 2 · General, Plastic Surgery
221
Registered devices
156
Adverse events
4
Recalls
35
510(k) clearances
Devices with this code
Clear & Brilliant — SOLTA MEDICALApolomed — Shanghai Apolo Medical Technology Co.,LtdEdge Guide Tip — Jeisys Medical Inc.ResurFX™ Head — LUMENIS BE LTDeCO2 3D — Cynosure Lutronic Technology CorporationSmooth Beauty Eye Wrinkle Laser — Tria Laser IncMIRIA — Avava, Inc.M22 Universal IPL Filter Kit — LUMENIS LTD.ResurFX Handpiece — LUMENIS LTD.ICON CONTROL MODULE REMAN — Cynosure, LLCEdge Guide Tip — Jeisys Medical Inc.Max Rs Handpiece — Cynosure, LLCM22 Q-Switch Lens Assembly & 6mm Metal Treatment Tip Kit — LUMENIS LTD.Max G Handpiece — Cynosure, LLCFocal Guide 6 x 6 — Cynosure, LLCEdge Guide Tip — Jeisys Medical Inc.Fraxis Zoom Handpiece — CLASSYS Inc.Fraxis Handpiece — CLASSYS Inc.Universal IPL 590 nm Expert Filter — LUMENIS LTD.Stellar SapphireCool LG 15x35 — LUMENIS LTD.Stellar M22 Acne filter — LUMENIS LTD.eCO2 3D — Cynosure Lutronic Technology Corporation2940 handpiece — Cynosure, LLCeCO2 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.