Cleared Traditional

K881494 - FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER

K881494 is an FDA 510(k) clearance for FOUR MODIFICATIONS TO OPHTHALAS ARGON/D..., manufactured by Biophysic Medical, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K881494 · Biophysic Medical, Inc. · Ophthalmic device
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Aug 1988
Decision
144d
Days
Class 2
Risk

K881494 is an FDA 510(k) clearance for the FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Biophysic Medical, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on August 30, 1988 after a review of 144 days - within the typical 510(k) review window.

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.

View all Biophysic Medical, Inc. devices

FDA 510(k) Submission Details - K881494

510(k) Number K881494 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 08, 1988
Decision Date August 30, 1988
Days to Decision 144 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 110d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQF Device Classification - Class 2, Special Controls

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 144
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K881494.
LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEM
K885164 · Chiron Vision Corp. · Jan 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
SLT CONTACT LASER SYSTEM OCULOPLASTICS
K881134 · Surgical Laser Technologies, Inc. · Jun 1988
PRISMA DISPOSABLE ENDO-OCULAR PROBE
K875000 · Advanced Surgical Products, Inc. · Apr 1988