Cleared Traditional

K912112 - PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480

K912112 is an FDA 510(k) clearance for PF-400, manufactured by Tomey Corporation USA. The device is a Class 2 Ophthalmic device with product code LQJ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K912112 · Tomey Corporation USA · Ophthalmic device
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Jun 1991
Decision
35d
Days
Class 2
Risk

K912112 is an FDA 510(k) clearance for the PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480. Classified as Lens, Surgical, Laser, Accesssory, Ophthalmic Laser (product code LQJ), Class II - Special Controls.

Submitted by Tomey Corporation USA (Cambridge, US). The FDA issued a Cleared decision on June 17, 1991 after a review of 35 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 Tomey Corporation USA devices

FDA 510(k) Submission Details - K912112

510(k) Number K912112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1991
Decision Date June 17, 1991
Days to Decision 35 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
75d faster than avg
Panel avg: 110d · This submission: 35d
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 7
Devices cleared under the same product code (LQJ) and FDA review panel - the closest regulatory comparables to K912112.
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
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