Cleared Traditional

K945346 - MAKROLON 2405 GOGGLES (LIGHT AND DARK)

K945346 is an FDA 510(k) clearance for MAKROLON 2405 GOGGLES (LIGHT AND DARK), manufactured by Universal Massage & Tanning, Inc.. The device is a Class 1 Ophthalmic device with product code HOY cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K945346 · Universal Massage & Tanning, Inc. · Ophthalmic device
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Nov 1994
Decision
20d
Days
Class 1
Risk

K945346 is an FDA 510(k) clearance for the MAKROLON 2405 GOGGLES (LIGHT AND DARK). Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by Universal Massage & Tanning, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4750 - 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 Universal Massage & Tanning, Inc. devices

FDA 510(k) Submission Details - K945346

510(k) Number K945346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1994
Decision Date November 22, 1994
Days to Decision 20 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 110d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

HOY Device Classification - Class 1, General Controls

Product Code HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)

All 16
Devices cleared under the same product code (HOY) and FDA review panel - the closest regulatory comparables to K945346.
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NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
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SHAIDS PROTECTIVE GLASSES
K930347 · Depuy, Inc. · Apr 1994
MODIFICATION OF SURGICAL EYESHIELD MASK
K934085 · American Threshold Industries, Inc. · Nov 1993
EYE BUBBLE
K912367 · Aaron Medical Industries · Oct 1991