510(k) K252979
K252979 is an FDA 510(k) premarket notification submitted by Belkin Vision, Ltd. for the device "Voyager DSLT (430840610)". The FDA issued a decision of Substantially Equivalent on April 7, 2026. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Belkin Vision, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 2026
- Date Received
- September 17, 2025
- 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