Cleared Traditional

GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT (K941660) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941660 · Gm Engineering, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
49d
Days
Class 2
Risk

K941660 is an FDA 510(k) clearance for the GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT. Classified as Endoscope, Ophthalmic (product code KYH), Class II - Special Controls.

Submitted by Gm Engineering, Inc. (La Verne, US). The FDA issued a Cleared decision on May 24, 1994 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - 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 Gm Engineering, Inc. devices

Submission Details

510(k) Number K941660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1994
Decision Date May 24, 1994
Days to Decision 49 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
61d faster than avg
Panel avg: 110d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KYH Endoscope, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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.