Cleared Traditional

K963075 - FITO DIDO

K963075 is an FDA 510(k) clearance for FITO DIDO, manufactured by Framesmart, Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K963075 · Framesmart, Inc. · Ophthalmic device
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Aug 1996
Decision
29d
Days
Class 1
Risk

K963075 is an FDA 510(k) clearance for the FITO DIDO. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Framesmart, Inc. (Miami, US). The FDA issued a Cleared decision on August 22, 1996 after a review of 29 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 Framesmart, Inc. devices

FDA 510(k) Submission Details - K963075

510(k) Number K963075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1996
Decision Date August 22, 1996
Days to Decision 29 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
81d faster than avg
Panel avg: 110d · This submission: 29d
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 K963075.
RAVEN EYE- EYE WEAR (SUNGLASSES)
K963284 · Raven Eye, Inc. · Aug 1996
SUNQUEST INTERNATIONAL
K963059 · Sunquest Intl., Inc. · Aug 1996
MARCELLA CARAN
K962912 · Framesmart, Inc. · Aug 1996
EAGLE EYES SUNGLASSES
K962287 · Positive Response Television · Aug 1996
CENTER OPTICAL GLASSES
K962298 · Mirage Eyewear, Inc. · Jul 1996
XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD.
K962382 · Xiamen Chingsong Optical Industrial Co., Ltd. · Jul 1996