K233473 is an FDA 510(k) clearance for the DEKA LOTUS, a Powered Light Based Non-laser Surgical Instrument With Thermal Effect (Class II — Special Controls, product code ONF), submitted by El.En S.P.A. (Calenzano, IT). The FDA issued a Cleared decision on May 16, 2024, 204 days after receiving the submission on October 25, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K233473 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 25, 2023 |
| Decision Date | May 16, 2024 |
| Days to Decision | 204 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. |