510(k) K250281
K250281 is an FDA 510(k) premarket notification submitted by El.En S.P.A. for the device "DEKA LOTUS". The FDA issued a decision of Substantially Equivalent on February 26, 2025. The device falls under product code ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect), a Class II device regulated under 21 CFR 878.4810. El.En S.P.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 2025
- Date Received
- January 31, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
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.