K062258 is an FDA 510(k) clearance for the GENESIS DIODE LASER, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on March 21, 2007, 229 days after receiving the submission on August 4, 2006. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K062258 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 04, 2006 |
| Decision Date | March 21, 2007 |
| Days to Decision | 229 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEX — Powered Laser Surgical Instrument |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | 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, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light. |