510(k) K030146
K030146 is an FDA 510(k) premarket notification submitted by Kavo America for the device "KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+". The FDA issued a decision of Substantially Equivalent on Aug 3, 2005. The device falls under product code NVK (Laser, Dental, Soft Tissue), a Class II device regulated under 21 CFR 878.4810. Kavo America has 19 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 2005
- Date Received
- Jan 15, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Laser, Dental, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- DE
- Submission Type
- 510(k)
Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.