Cleared Traditional

K964380 - LC-250 INFRARED LIGHT COAGULATOR

K964380 is an FDA 510(k) clearance for LC-250 INFRARED LIGHT COAGULATOR, manufactured by Nk-Optik America. The device is a Class 2 Ophthalmic device with product code HQB cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K964380 · Nk-Optik America · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
79d
Days
Class 2
Risk

K964380 is an FDA 510(k) clearance for the LC-250 INFRARED LIGHT COAGULATOR. Classified as Photocoagulator And Accessories (product code HQB), Class II - Special Controls.

Submitted by Nk-Optik America (Chicago, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4690 - 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.

FDA 510(k) Submission Details - K964380

510(k) Number K964380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1996
Decision Date January 22, 1997
Days to Decision 79 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
31d faster than avg
Panel avg: 110d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQB Device Classification - Class 2, Special Controls

Product Code HQB Photocoagulator And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4690
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 - HQB Photocoagulator And Accessories

All 29
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K964380.
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
K110951 · Alcon Research, Ltd. · Oct 2011
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
K111493 · Nidek Co., Ltd. · Jul 2011
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
K110228 · Nidek Incorporated · Feb 2011
GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE
K954306 · Gamp & Assoc. · Dec 1995
GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE
K954307 · Gamp & Assoc. · Dec 1995
GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE
K954308 · Gamp & Assoc. · Dec 1995
K964380 · LC-250 INFRARED LIGHT COAGULATOR
Download PDF Nk-Optik America