Cleared Traditional

K842412 - MODEL 4000 MD-YAG LASER FOR MALIGNANT

K842412 is an FDA 510(k) clearance for MODEL 4000 MD-YAG LASER FOR MALIGNANT, 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 7-day FDA review.

K842412 · Cooper Lasersonics, Inc. · Ophthalmic device
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Jun 1984
Decision
7d
Days
Class 2
Risk

K842412 is an FDA 510(k) clearance for the MODEL 4000 MD-YAG LASER FOR MALIGNANT. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Cooper Lasersonics, Inc. (Walker, US). The FDA issued a Cleared decision on June 26, 1984 after a review of 7 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 - K842412

510(k) Number K842412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1984
Decision Date June 26, 1984
Days to Decision 7 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
103d faster than avg
Panel avg: 110d · This submission: 7d
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 K842412.
MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS
K854949 · CooperVision, Inc. · Feb 1986
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MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE
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MONITOR CO2 LASER SURGICAL SYSTEM
K840145 · Cooper Lasersonics, Inc. · Apr 1984
ARGON/KRYPTON ION LASER PHOTOCOAGULA
K834305 · Nidek, Inc. · Mar 1984
MODEL 900S INTRAOCULAR PROBE
K812219 · Lumenis, Inc. · Nov 1981