Cleared Traditional

K844668 - MODEL 8000 ND:YAG LASER SYS TREATMENT O...

K844668 is an FDA 510(k) clearance for MODEL 8000 ND:YAG LASER SYS TREATMENT O..., manufactured by Cooper Lasersonics, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K844668 · Cooper Lasersonics, Inc. · Ophthalmic device
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Jan 1985
Decision
34d
Days
Class 2
Risk

K844668 is an FDA 510(k) clearance for the MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on January 3, 1985 after a review of 34 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 Cooper Lasersonics, Inc. devices

FDA 510(k) Submission Details - K844668

510(k) Number K844668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1984
Decision Date January 03, 1985
Days to Decision 34 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
76d faster than avg
Panel avg: 110d · This submission: 34d
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 80
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K844668.
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
MODEL 4000 MD-YAG LASER FOR MALIGNANT
K842412 · Cooper Lasersonics, Inc. · Jun 1984
MONITOR CO2 LASER SURGICAL SYSTEM
K840145 · Cooper Lasersonics, Inc. · Apr 1984
ARGON/KRYPTON ION LASER PHOTOCOAGULA
K834305 · Nidek, Inc. · Mar 1984