Cleared Traditional

K990075 - LPULSA SYL-9000 OPHTHALMIC YAG LASER

K990075 is the FDA 510(k) clearance for LPULSA SYL-9000 OPHTHALMIC YAG LASER by Light-Med(Usa), Inc.. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K990075 · Light-Med(Usa), Inc. · Ophthalmic device
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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.

View all Light-Med(Usa), Inc. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 110d · 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.

Regulatory Peers - HQF Laser, Ophthalmic

All 64
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