Cleared Traditional

K831231 - LED GOGGLES

K831231 is an FDA 510(k) clearance for LED GOGGLES, manufactured by Cadwell Laboratories, Inc.. The device is a Class 2 Ophthalmic device with product code HLX cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K831231 · Cadwell Laboratories, Inc. · Ophthalmic device
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May 1983
Decision
31d
Days
Class 2
Risk

K831231 is an FDA 510(k) clearance for the LED GOGGLES. Classified as Photostimulator, Ac-powered (product code HLX), Class II - Special Controls.

Submitted by Cadwell Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1983 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1630 - 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 Cadwell Laboratories, Inc. devices

FDA 510(k) Submission Details - K831231

510(k) Number K831231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1983
Decision Date May 16, 1983
Days to Decision 31 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
79d faster than avg
Panel avg: 110d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLX Device Classification - Class 2, Special Controls

Product Code HLX Photostimulator, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HLX Photostimulator, Ac-powered

All 7
Devices cleared under the same product code (HLX) and FDA review panel - the closest regulatory comparables to K831231.
CLARUS ENDOSCOPIC HOOK KNIFE
K925741 · Clarus Medical Systems, Inc. · Aug 1993
CONTRAST SENSITIVITY EQUIPMENT
K830770 · Cadwell Laboratories, Inc. · Apr 1983
5031 BRIGHT FLASH STIMULATOR
K822915 · Life-Tech Intl., Inc. · Dec 1982
5010 VISUSTIM
K822919 · Life-Tech Intl., Inc. · Dec 1982
5011 GANZFELD STIMULATOR
K822922 · Life-Tech Intl., Inc. · Dec 1982
5012 PARABOLIC STIMULATOR
K822923 · Life-Tech Intl., Inc. · Dec 1982