Cleared Traditional

K924090 - THE ENDO OPTIKS MICROPROBE

K924090 is an FDA 510(k) clearance for THE ENDO OPTIKS MICROPROBE, manufactured by Endo Optics, Inc.. The device is a Class 2 Ophthalmic device with product code HQB cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K924090 · Endo Optics, Inc. · Ophthalmic device
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Feb 1993
Decision
172d
Days
Class 2
Risk

K924090 is an FDA 510(k) clearance for the THE ENDO OPTIKS MICROPROBE. Classified as Photocoagulator And Accessories (product code HQB), Class II - Special Controls.

Submitted by Endo Optics, Inc. (Marlboro, US). The FDA issued a Cleared decision on February 1, 1993 after a review of 172 days - an extended review 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: 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 Endo Optics, Inc. devices

FDA 510(k) Submission Details - K924090

510(k) Number K924090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1992
Decision Date February 01, 1993
Days to Decision 172 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
62d slower than avg
Panel avg: 110d · This submission: 172d
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 25
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K924090.
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
K111493 · Nidek Co., Ltd. · Jul 2011
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
K110228 · Nidek Incorporated · Feb 2011
LC-250 INFRARED LIGHT COAGULATOR
K964380 · Nk-Optik America · Jan 1997
ZIESS ENDOPROBE
K922735 · Carl Zeiss, Inc. · Jul 1992
SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION
K882679 · Surgical Laser Technologies, Inc. · Dec 1988
SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION
K882441 · Surgical Laser Technologies, Inc. · Sep 1988