Cleared Traditional

K990075 - LPULSA SYL-9000 OPHTHALMIC YAG LASER (FDA 510(k) Clearance)

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

K990075 · Light-Med(Usa), Inc. · Ophthalmic device
Mar 1999
Decision
78d
Days
Class 2
Risk

K990075 is an FDA 510(k) clearance for the LPULSA SYL-9000 OPHTHALMIC YAG LASER. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Light-Med(Usa), Inc. (Laguna Hills, US). The FDA issued a Cleared decision on March 30, 1999 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K990075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1999
Decision Date March 30, 1999
Days to Decision 78 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 156d · This submission: 78d
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.