K091125 is an FDA 510(k) clearance for the CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2. This device is classified as a Powered Light Based Non-laser Surgical Instrument (Class II - Special Controls, product code ONE).
Submitted by Verilux (South St. Paul, US). The FDA issued a Cleared decision on September 3, 2010, 504 days after receiving the submission on April 17, 2009.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. A Light Based Non-laser Device Typically Indicated To Be Used 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. Indication For Use Can Be General And/or Specific. 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..
| 510(k) Number | K091125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2009 |
| Decision Date | September 03, 2010 |
| Days to Decision | 504 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | ONE — Powered Light Based Non-laser Surgical Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | A Light Based Non-laser Device Typically Indicated To Be Used 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. Indication For Use Can Be General And/or Specific. 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. |