Cleared Traditional

K152688 - LightLas Multi-Wavelength Medical Laser System

K152688 is an FDA 510(k) clearance for LightLas Multi-Wavelength Medical Laser..., manufactured by Lightmed Corporation. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K152688 · Lightmed Corporation · Ophthalmic device
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Jun 2016
Decision
271d
Days
Class 2
Risk

K152688 is an FDA 510(k) clearance for the LightLas Multi-Wavelength Medical Laser System. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Lightmed Corporation (New Taipei City, TW). The FDA issued a Cleared decision on June 15, 2016 after a review of 271 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 Lightmed Corporation devices

FDA 510(k) Submission Details - K152688

510(k) Number K152688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2015
Decision Date June 15, 2016
Days to Decision 271 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
161d slower than avg
Panel avg: 110d · This submission: 271d
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

All 137
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K152688.
Easyret
K170067 · Quantel Medical · Jul 2017
YELLOW LASER PHOTOCOAGULATOR YLC-500
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R:GEN Laser System
K153769 · Lutronic Corporation · Oct 2016
Green Laser Photocoagulator GYC-500
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Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow
K142398 · Ellex Medical Pty, Ltd. · Jul 2015
Ophthalmed Bending Laser Probes
K142830 · Ophthalmed, LLC · Jun 2015