510(k) K213428
K213428 is an FDA 510(k) premarket notification submitted by Biolase, Inc. for the device "EdgePro". The FDA issued a decision of Substantially Equivalent on December 22, 2021. The device falls under product code NVK (Laser, Dental, Soft Tissue), a Class II device regulated under 21 CFR 878.4810. Biolase, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2021
- Date Received
- October 21, 2021
- Clearance Type
- Special
- 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
Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.