510(k) K201502
K201502 is an FDA 510(k) premarket notification submitted by Quantel Medical for the device "Vitra 810". The FDA issued a decision of Substantially Equivalent on August 6, 2020. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Quantel Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 2020
- Date Received
- June 5, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.4390
- Review Panel
- OP
- Submission Type