Cleared Traditional

K885164 - LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER...

K885164 is the FDA 510(k) clearance for LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER... by Chiron Vision Corp.. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K885164 · Chiron Vision Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1989
Decision
28d
Days
Class 2
Risk

K885164 is an FDA 510(k) clearance for the LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEM. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Chiron Vision Corp. (Irvine, US). The FDA issued a Cleared decision on January 10, 1989 after a review of 28 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 Chiron Vision Corp. devices

Submission Details

510(k) Number K885164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1988
Decision Date January 10, 1989
Days to Decision 28 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
82d faster than avg
Panel avg: 110d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQF Laser, Ophthalmic
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 - HQF Laser, Ophthalmic

All 64
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K885164.
NIDEK MODEL AKC-8000
K894273 · Nidek, Inc. · Aug 1989
CANDELA UPC LASER PHOTOCOAGULATOR
K893630 · Candela Laser Corp. · Aug 1989
MICROLASE 8 0 0 (OPHTHALMIC LASER)
K890086 · Keeler Instruments, Inc. · Mar 1989
SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA.
K882908 · Surgical Laser Technologies, Inc. · Sep 1988
NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)
K883213 · Nidek, Inc. · Sep 1988
RESUBMITTED DIODE LASER COAGULATOR
K882372 · CooperVision, Inc. · Aug 1988