Cleared Traditional

K830770 - CONTRAST SENSITIVITY EQUIPMENT

K830770 is an FDA 510(k) clearance for CONTRAST SENSITIVITY EQUIPMENT, 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 48-day FDA review.

K830770 · Cadwell Laboratories, Inc. · Ophthalmic device
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Apr 1983
Decision
48d
Days
Class 2
Risk

K830770 is an FDA 510(k) clearance for the CONTRAST SENSITIVITY EQUIPMENT. 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 April 28, 1983 after a review of 48 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 - K830770

510(k) Number K830770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1983
Decision Date April 28, 1983
Days to Decision 48 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
62d faster than avg
Panel avg: 110d · This submission: 48d
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 K830770.
CLARUS ENDOSCOPIC HOOK KNIFE
K925741 · Clarus Medical Systems, Inc. · Aug 1993
LED GOGGLES
K831231 · Cadwell Laboratories, Inc. · May 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