Cleared Traditional

K240615 - Leos Laser and Endoscopy System (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240615 · Beaver-Visitec International, Inc. · Ophthalmic device
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Apr 2025
Decision
394d
Days
Class 2
Risk

K240615 is an FDA 510(k) clearance for the Leos Laser and Endoscopy System. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Beaver-Visitec International, Inc. (Waltham, US). The FDA issued a Cleared decision on April 3, 2025 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Beaver-Visitec International, Inc. devices

Submission Details

510(k) Number K240615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2024
Decision Date April 03, 2025
Days to Decision 394 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
284d slower than avg
Panel avg: 110d · This submission: 394d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - HQF Laser, Ophthalmic

All 179
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