Cleared Traditional

K862987 - MODEL 1000 OPHTHALMIC LASER SYSTEM

K862987 is an FDA 510(k) clearance for MODEL 1000 OPHTHALMIC LASER SYSTEM, manufactured by CooperVision, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K862987 · CooperVision, Inc. · Ophthalmic device
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Sep 1986
Decision
48d
Days
Class 2
Risk

K862987 is an FDA 510(k) clearance for the MODEL 1000 OPHTHALMIC LASER SYSTEM. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by CooperVision, Inc. (Santa Clara, US). The FDA issued a Cleared decision on September 24, 1986 after a review of 48 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 CooperVision, Inc. devices

FDA 510(k) Submission Details - K862987

510(k) Number K862987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1986
Decision Date September 24, 1986
Days to Decision 48 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
62d faster than avg
Panel avg: 110d · This submission: 48d
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 K862987.
MIRALITE
K863246 · Mira, Inc. · Oct 1986
ENDOPHOTOCOAGULATION PROBE
K863591 · Mira, Inc. · Oct 1986
LDS - LASER DELIVERY SYSTEM
K862568 · Coherent Medical Group · Oct 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
OPHTHALMIC LASER PHOTOCOAGULATOR
K853890 · Mira, Inc. · Nov 1985