Cleared Traditional

K960522 - DIOPEXY PROBE

K960522 is an FDA 510(k) clearance for DIOPEXY PROBE, manufactured by Iriderm Div.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K960522 · Iriderm Div. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
164d
Days
Class 2
Risk

K960522 is an FDA 510(k) clearance for the DIOPEXY PROBE. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Iriderm Div. (Mountain View, US). The FDA issued a Cleared decision on July 19, 1996 after a review of 164 days - an extended review 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: 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 Iriderm Div. devices

FDA 510(k) Submission Details - K960522

510(k) Number K960522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1996
Decision Date July 19, 1996
Days to Decision 164 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
54d slower than avg
Panel avg: 110d · This submission: 164d
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 118
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K960522.
INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER
K971950 · Infinitech, Inc. · Aug 1997
CERALAS DIODE LASER SYSTEM (CERALAS D2)
K964751 · Ceram Optec, Inc. · Feb 1997
OCULIGHT GL
K960971 · Iriderm Div. · Aug 1996
NIDEK MODEL GYC-1500 AND GYC-2000
K951079 · Nidek, Inc. · Sep 1995
VISULINK 900 ARGON
K952894 · Carl Zeiss, Inc. · Aug 1995
KEELER MULTILASE 3000
K942180 · Keeler Instruments, Inc. · Nov 1994