510(k) K092800
K092800 is an FDA 510(k) premarket notification submitted by Led Intellectual Properties, LLC for the device "ANTI-WRINKLE (AGING) LIGHT, MODEL AAL". The FDA issued a decision of Substantially Equivalent on February 4, 2010. The device falls under product code ONE (Powered Light Based Non-Laser Surgical Instrument), a Class II device regulated under 21 CFR 878.4810. Led Intellectual Properties, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2010
- Date Received
- September 11, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powered Light Based Non-Laser Surgical Instrument
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
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.