Cleared Traditional

K923531 - OPTOSCALPEL I LASER SYSTEM

K923531 is an FDA 510(k) clearance for OPTOSCALPEL I LASER SYSTEM, manufactured by Optomed Corp.. The device is a Class 2 Ophthalmic device with product code HQB cleared through the Traditional 510(k) pathway after a 484-day FDA review.

K923531 · Optomed Corp. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
484d
Days
Class 2
Risk

K923531 is an FDA 510(k) clearance for the OPTOSCALPEL I LASER SYSTEM. Classified as Photocoagulator And Accessories (product code HQB), Class II - Special Controls.

Submitted by Optomed Corp. (Austin, US). The FDA issued a Cleared decision on November 12, 1993 after a review of 484 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

FDA 510(k) Submission Details - K923531

510(k) Number K923531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1992
Decision Date November 12, 1993
Days to Decision 484 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
374d slower than avg
Panel avg: 110d · This submission: 484d
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 K923531.
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
THE ENDO OPTIKS MICROPROBE
K924090 · Endo Optics, Inc. · Feb 1993
ZIESS ENDOPROBE
K922735 · Carl Zeiss, Inc. · Jul 1992
SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION
K882679 · Surgical Laser Technologies, Inc. · Dec 1988
K923531 · OPTOSCALPEL I LASER SYSTEM
Download PDF FDA Summary Optomed Corp.