Cleared Traditional

K962522 - MODEL SL-YZ5E

K962522 is an FDA 510(k) clearance for MODEL SL-YZ5E, manufactured by Pacific Ophthalmic Supply. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K962522 · Pacific Ophthalmic Supply · Ophthalmic device
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Jul 1996
Decision
41d
Days
Class 2
Risk

K962522 is an FDA 510(k) clearance for the MODEL SL-YZ5E. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Pacific Ophthalmic Supply (Belmont, US). The FDA issued a Cleared decision on July 25, 1996 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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 Pacific Ophthalmic Supply devices

FDA 510(k) Submission Details - K962522

510(k) Number K962522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1996
Decision Date July 25, 1996
Days to Decision 41 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 110d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJO Device Classification - Class 2, Special Controls

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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 - HJO Biomicroscope, Slit-lamp, Ac-powered

All 47
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K962522.
AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08
K974467 · Aesculap-Meditec North America · Feb 1998
CONFOSCAN
K971953 · Tomey Corporation USA · Aug 1997
CONFOCAL MICROSCOPE
K970414 · Con-S , Ltd. · Jul 1997
RODENSTOCK SLITLAMP (MODEL 5000 & 4000)
K962532 · Expertech Assoc., Inc. · Jul 1996
NEITZ SLIT LAMP SL-H2
K951341 · Neitz Instruments Company, Ltd. · Jun 1995
NEITZ SLIT LAMP SL-H1
K951340 · Neitz Instruments Company, Ltd. · Apr 1995