Cleared Traditional

K944402 - FOCOMETER

K944402 is an FDA 510(k) clearance for FOCOMETER, manufactured by Lacrimedics, Inc.. The device is a Class 2 Ophthalmic device with product code HLJ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K944402 · Lacrimedics, Inc. · Ophthalmic device
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Nov 1994
Decision
71d
Days
Class 2
Risk

K944402 is an FDA 510(k) clearance for the FOCOMETER. Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by Lacrimedics, Inc. (Rialto, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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 Lacrimedics, Inc. devices

FDA 510(k) Submission Details - K944402

510(k) Number K944402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1994
Decision Date November 22, 1994
Days to Decision 71 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 110d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLJ Device Classification - Class 2, Special Controls

Product Code HLJ Ophthalmoscope, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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 - HLJ Ophthalmoscope, Battery-powered

All 30
Devices cleared under the same product code (HLJ) and FDA review panel - the closest regulatory comparables to K944402.
HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134
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RI-SCOPE S OTOSCOPE
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K942717 · Neitz Instruments Company, Ltd. · Aug 1994
NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR
K942719 · Neitz Instruments Company, Ltd. · Aug 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13
K942721 · Neitz Instruments Company, Ltd. · Aug 1994