Cleared Traditional

K893731 - SHIELDS T.C. LASER LENS

K893731 is the FDA 510(k) clearance for SHIELDS T.C. LASER LENS by Ocular Instruments, Inc.. It is a Class 2 Ophthalmic device (product code LQJ) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K893731 · Ocular Instruments, Inc. · Ophthalmic device
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Aug 1989
Decision
92d
Days
Class 2
Risk

K893731 is an FDA 510(k) clearance for the SHIELDS T.C. LASER LENS. Classified as Lens, Surgical, Laser, Accesssory, Ophthalmic Laser (product code LQJ), Class II - Special Controls.

Submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on August 17, 1989 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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 Ocular Instruments, Inc. devices

Submission Details

510(k) Number K893731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1989
Decision Date August 17, 1989
Days to Decision 92 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
18d faster than avg
Panel avg: 110d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
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 - LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser

Devices cleared under the same product code (LQJ) and FDA review panel - the closest regulatory comparables to K893731.
TROKEL /3 GONIO LASER LENS
K921414 · Ocular Instruments, Inc. · Nov 1992
BOLDREY PERIPHERAL RETINAL LENS
K882574 · Ocular Instruments, Inc. · Jul 1988
TROKEL SINGLE MIRROR YAG LASER LENS
K872802 · Ocular Instruments, Inc. · Sep 1987
LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1
K871245 · Chiron Vision Corp. · May 1987
SCHIRMER NYLON SUTURE LASER LENS
K871099 · Ocular Instruments, Inc. · Apr 1987
PETRUS SINGLE MIRROR LASER LENS
K862869 · Ocular Instruments, Inc. · Aug 1986