Cleared Traditional

K914095 - PEEPERS TANNING GOGGLES

K914095 is an FDA 510(k) clearance for PEEPERS TANNING GOGGLES, manufactured by California Suncare, Inc.. The device is a Class 1 General & Plastic Surgery device with product code HOY cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K914095 · California Suncare, Inc. · General & Plastic Surgery device
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Oct 1991
Decision
48d
Days
Class 1
Risk

K914095 is an FDA 510(k) clearance for the PEEPERS TANNING GOGGLES. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by California Suncare, Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 30, 1991 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 886.4750 - the FDA general and plastic surgery 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 California Suncare, Inc. devices

FDA 510(k) Submission Details - K914095

510(k) Number K914095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1991
Decision Date October 30, 1991
Days to Decision 48 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 115d · This submission: 48d
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 K914095.
NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
K971465 · National Healthcare Mfg. Corp. · Jun 1997
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
UNIDIRECTIONAL OCCLUDER
K913230 · Welch Allyn, Inc. · Oct 1991
SOFT CORNEAL LIGHT SHIELD
K896681 · Visitec Co. · Jan 1990