Cleared Traditional

K872802 - TROKEL SINGLE MIRROR YAG LASER LENS

K872802 is the FDA 510(k) clearance for TROKEL SINGLE MIRROR YAG 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 51-day FDA review.

K872802 · Ocular Instruments, Inc. · Ophthalmic device
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Sep 1987
Decision
51d
Days
Class 2
Risk

K872802 is an FDA 510(k) clearance for the TROKEL SINGLE MIRROR YAG 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 September 4, 1987 after a review of 51 days - a notably fast clearance 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: 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 Ocular Instruments, Inc. devices

Submission Details

510(k) Number K872802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1987
Decision Date September 04, 1987
Days to Decision 51 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
59d faster than avg
Panel avg: 110d · This submission: 51d
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 K872802.
TROKEL /3 GONIO LASER LENS
K921414 · Ocular Instruments, Inc. · Nov 1992
SHIELDS T.C. LASER LENS
K893731 · Ocular Instruments, Inc. · Aug 1989
BOLDREY PERIPHERAL RETINAL LENS
K882574 · Ocular Instruments, Inc. · Jul 1988
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