Cleared Traditional

K921414 - TROKEL /3 GONIO LASER LENS

K921414 is an FDA 510(k) clearance for TROKEL /3 GONIO LASER LENS, manufactured by Ocular Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code LQJ cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K921414 · Ocular Instruments, Inc. · Ophthalmic device
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Nov 1992
Decision
237d
Days
Class 2
Risk

K921414 is an FDA 510(k) clearance for the TROKEL /3 GONIO 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 November 16, 1992 after a review of 237 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K921414

510(k) Number K921414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1992
Decision Date November 16, 1992
Days to Decision 237 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
127d slower than avg
Panel avg: 110d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQJ Device Classification - Class 2, Special Controls

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

All 12
Devices cleared under the same product code (LQJ) and FDA review panel - the closest regulatory comparables to K921414.
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K912112 · Tomey Corporation USA · Jun 1991
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K893731 · Ocular Instruments, Inc. · Aug 1989
MQL 20 ND:YAG OPHTHALMIC LASER
K884694 · California Laboratories, Inc. · Nov 1988
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K883719 · Biophysic Medical, Inc. · Oct 1988
K921414 · TROKEL /3 GONIO LASER LENS
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