Cleared Traditional

K091981 - LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEM...

K091981 is an FDA 510(k) clearance for LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEM..., manufactured by Lightmed Corp.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K091981 · Lightmed Corp. · Ophthalmic device
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Sep 2009
Decision
89d
Days
Class 2
Risk

K091981 is an FDA 510(k) clearance for the LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Lightmed Corp. (Taipei, TW). The FDA issued a Cleared decision on September 28, 2009 after a review of 89 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 Lightmed Corp. devices

FDA 510(k) Submission Details - K091981

510(k) Number K091981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2009
Decision Date September 28, 2009
Days to Decision 89 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 110d · This submission: 89d
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 Peers - HQF Laser, Ophthalmic

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