Voyager DSLT (430840610)— 510(k) K252979

Substantially Equivalent

Belkin Vision, Ltd.

FDA 510(k) clearance K252979 for Voyager DSLT (430840610), Substantially Equivalent on 2026-04-07. Applicant: Belkin Vision, Ltd.. Device class: 2.

Summary

Belkin Vision's Voyager DSLT (430840610) is filed under product code HQF (Laser, Ophthalmic). The record doesn't spell out DSLT or describe the laser beyond its name and that code name.

Class II, 21 CFR 886.4390. It came in as a Traditional 510(k), and Ophthalmic is both the classification panel and the review panel.

Belkin Vision filed from Yavne, Israel. Review took 202 calendar days (September 17, 2025 to April 7, 2026).

Clearance details

Applicant
Belkin Vision, Ltd.
Product code
Product code HQF
Device class
Class 2
Regulation
21 CFR 886.4390
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Yavne, IL
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HQF

product code HQF
Injury
166
Other
1
Total
167

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.