Cleared Traditional

K252979 - Voyager DSLT (430840610)

K252979 is an FDA 510(k) clearance for Voyager DSLT (430840610), manufactured by Belkin Vision, Ltd.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K252979 · Belkin Vision, Ltd. · Ophthalmic device
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Apr 2026
Decision
202d
Days
Class 2
Risk

K252979 is an FDA 510(k) clearance for the Voyager DSLT (430840610). Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Belkin Vision, Ltd. (Yavne, IL). The FDA issued a Cleared decision on April 7, 2026 after a review of 202 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Belkin Vision, Ltd. devices

FDA 510(k) Submission Details - K252979

510(k) Number K252979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2025
Decision Date April 07, 2026
Days to Decision 202 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 110d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQF Device Classification - Class 2, Special Controls

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Regulatory Pathways Group, Inc.
Anne-Marie Ripley

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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