510(k) K100628
K100628 is an FDA 510(k) premarket notification submitted by Daavlin Distributing Co. for the device "PLASMALUXLS". The FDA issued a decision of Substantially Equivalent on November 24, 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. Daavlin Distributing Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 2010
- Date Received
- March 5, 2010
- 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.