Cleared Traditional

K862568 - LDS - LASER DELIVERY SYSTEM

K862568 is the FDA 510(k) clearance for LDS - LASER DELIVERY SYSTEM by Coherent Medical Group. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K862568 · Coherent Medical Group · Ophthalmic device
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Oct 1986
Decision
92d
Days
Class 2
Risk

K862568 is an FDA 510(k) clearance for the LDS - LASER DELIVERY SYSTEM. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Coherent Medical Group (Palo Alto, US). The FDA issued a Cleared decision on October 7, 1986 after a review of 92 days - within the typical 510(k) review window.

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 Coherent Medical Group devices

Submission Details

510(k) Number K862568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1986
Decision Date October 07, 1986
Days to Decision 92 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 110d · This submission: 92d
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 65
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K862568.
ZEISS VISULAS ARGON LASER
K874609 · Carl Zeiss, Inc. · Jan 1988
NIDEK ADC-8000 LASER SYSTEM
K872846 · Nidek, Inc. · Oct 1987
MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC
K870839 · Directed Energy, Inc. · May 1987
MODEL 1000 OPHTHALMIC LASER SYSTEM
K862987 · CooperVision, Inc. · Sep 1986
MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS
K854949 · CooperVision, Inc. · Feb 1986
HESSBURG GLIDE UNTRAOCULAR LENS GUIDES
K852529 · Visitec Co. · Sep 1985