Cleared Traditional

K901160 - NUBALOO(R) SUNGLASSES

K901160 is an FDA 510(k) clearance for NUBALOO SUNGLASSES, manufactured by Blublocker Corp.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K901160 · Blublocker Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
93d
Days
Class 1
Risk

K901160 is an FDA 510(k) clearance for the NUBALOO(R) SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Blublocker Corp. (Northbrook, US). The FDA issued a Cleared decision on June 14, 1990 after a review of 93 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K901160

510(k) Number K901160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1990
Decision Date June 14, 1990
Days to Decision 93 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
17d faster than avg
Panel avg: 110d · This submission: 93d
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 632
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K901160.
SUNGLASSES STYLE #(1137)
K901570 · Zaks Stores, Inc. · Jun 1990
SUNGLASSES STYLE #(CM-1989)
K901571 · Zaks Stores, Inc. · Jun 1990
SUNGLASSES STYLE #(70116)
K901572 · Zaks Stores, Inc. · Jun 1990
(EYEGLASS) FRAMES AND SUNGLASSES
K901167 · Optique Marquis, Div. Sugerose, Inc. · Jun 1990
NON-PRESCRIPTION SUNGLASSES
K901036 · The Bonneau Co. · Jun 1990
SUNGLASSES
K901047 · Command Marketing Corp. · May 1990
K901160 · NUBALOO(R) SUNGLASSES
Download PDF Blublocker Corp.