K213558 is an FDA 510(k) clearance for the IPL Hair Removal Device. 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 Ulike Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on March 8, 2022, 120 days after receiving the submission on November 8, 2021.
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 | K213558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2021 |
| Decision Date | March 08, 2022 |
| Days to Decision | 120 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. |