Cleared Traditional

K862568 - LDS - LASER DELIVERY SYSTEM

K862568 is an FDA 510(k) clearance for LDS - LASER DELIVERY SYSTEM, manufactured by Coherent Medical Group. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K862568

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
Combination Product No
PCCP Authorized No
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.

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 139
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K862568.
MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC
K870839 · Directed Energy, Inc. · May 1987
MIRALITE
K863246 · Mira, Inc. · Oct 1986
ENDOPHOTOCOAGULATION PROBE
K863591 · Mira, Inc. · Oct 1986
MODEL 1000 OPHTHALMIC LASER SYSTEM
K862987 · CooperVision, Inc. · Sep 1986
FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)
K860358 · Hgm, Inc. · Mar 1986
MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS
K854949 · CooperVision, Inc. · Feb 1986