Cleared Traditional

K955611 - KMANZ II

K955611 is an FDA 510(k) clearance for KMANZ II, manufactured by Gatorz LLC. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K955611 · Gatorz LLC · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
26d
Days
Class 1
Risk

K955611 is an FDA 510(k) clearance for the KMANZ II. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Gatorz LLC (San Diego, US). The FDA issued a Cleared decision on January 3, 1996 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5850 - 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 Gatorz LLC devices

FDA 510(k) Submission Details - K955611

510(k) Number K955611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1995
Decision Date January 03, 1996
Days to Decision 26 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 110d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

HQY Device Classification - Class 1, General Controls

Product Code HQY Sunglasses (non-prescription Including Photosensitive)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5850
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 - HQY Sunglasses (non-prescription Including Photosensitive)

All 123
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K955611.
MOONSHADES SUNGLASSES
K954659 · Blublocker Corp. · Jan 1996
SUNGLASSES WITH IMPACT RESISTANT LENSES
K955572 · Diamond Mark International Co., Ltd. · Jan 1996
UNISUN
K955539 · Steven Chen · Jan 1996
PHOTOCHROMIC LENS
K890725 · Ppg Industries, Inc. · Apr 1989
CALIUS-ISABEL CANOVAS SUNGLASSES
K890081 · Roseburg SA · Mar 1989
ASSENAT-BLESCHET SUNGLASSES
K885275 · Roseburg SA · Jan 1989