K082040 is an FDA 510(k) clearance for the MINISILK FT. This device is classified as a Powered Light Based Non-laser Surgical Instrument With Thermal Effect (Class II - Special Controls, product code ONF).
Submitted by El.En Electronic Engineering Spa (Calenzano, IT). The FDA issued a Cleared decision on August 27, 2009, 405 days after receiving the submission on July 18, 2008.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. A Light Based Non-laser Device That Provides Thermal Effect Including Broad Spectrum Source Devices Such As Intense Pulse Light (ipl). Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic. 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, Or Remove Tissue By The Light..
| 510(k) Number | K082040 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2008 |
| Decision Date | August 27, 2009 |
| Days to Decision | 405 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | ONF — Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | A Light Based Non-laser Device That Provides Thermal Effect Including Broad Spectrum Source Devices Such As Intense Pulse Light (ipl). Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic. 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, Or Remove Tissue By The Light. |