510(k) K220974
K220974 is an FDA 510(k) premarket notification submitted by Lutronic Vision, Inc. for the device "R:GEN". The FDA issued a decision of Substantially Equivalent on Dec 27, 2022. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 27, 2022
- Date Received
- Apr 4, 2022
- 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
- 510(k)