Cleared Traditional

K936199 - AUTOMATIC LENSOMETER

K936199 is an FDA 510(k) clearance for AUTOMATIC LENSOMETER, manufactured by Canon USA, Inc.. The device is a Class 1 Ophthalmic device with product code HLM cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K936199 · Canon USA, Inc. · Ophthalmic device
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Sep 1994
Decision
273d
Days
Class 1
Risk

K936199 is an FDA 510(k) clearance for the AUTOMATIC LENSOMETER. Classified as Instrument, Measuring, Lens, Ac-powered (product code HLM), Class I - General Controls.

Submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on September 28, 1994 after a review of 273 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1425 - 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.

View all Canon USA, Inc. devices

FDA 510(k) Submission Details - K936199

510(k) Number K936199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1993
Decision Date September 28, 1994
Days to Decision 273 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
163d slower than avg
Panel avg: 110d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

HLM Device Classification - Class 1, General Controls

Product Code HLM Instrument, Measuring, Lens, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1425
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 - HLM Instrument, Measuring, Lens, Ac-powered

All 8
Devices cleared under the same product code (HLM) and FDA review panel - the closest regulatory comparables to K936199.
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K924788 · R.H. Burton Co. · Apr 1993
WOODLYN CLASSIC LENSMETER
K920861 · Woodlyn, Inc. · Jul 1992
NIDEK LM-870 AUTOMATIC LENSMETER
K884188 · Nidek, Inc. · Nov 1988
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K862518 · Bausch & Lomb, Inc. · Aug 1986