Cleared Traditional

K834610 - LASER LENS-VARIOUS MODELS

K834610 is an FDA 510(k) clearance for LASER LENS-VARIOUS MODELS, manufactured by Meditec of America. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K834610 · Meditec of America · Ophthalmic device
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Apr 1984
Decision
106d
Days
Class 2
Risk

K834610 is an FDA 510(k) clearance for the LASER LENS-VARIOUS MODELS. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Meditec of America (Walker, US). The FDA issued a Cleared decision on April 5, 1984 after a review of 106 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 Meditec of America devices

FDA 510(k) Submission Details - K834610

510(k) Number K834610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1983
Decision Date April 05, 1984
Days to Decision 106 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 110d · This submission: 106d
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 145
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K834610.
AMER. MED. OPTICS ARGON/KRYPTON LASER
K841856 · American Medical Optics · Jun 1984
FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE
K840590 · Hgm, Inc. · May 1984
MONITOR CO2 LASER SURGICAL SYSTEM
K840145 · Cooper Lasersonics, Inc. · Apr 1984
MEDICAL LASER ENDOCOAGULATOR 5K
K840854 · Hgm, Inc. · Apr 1984
ARGON/KRYPTON ION LASER PHOTOCOAGULA
K834305 · Nidek, Inc. · Mar 1984
OPHTHALMIC ARGON LASER #700A
K832316 · Laser Industries , Ltd. · Jan 1984