Cleared Traditional

APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES (K082031) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082031 · Appasamy Associates · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
14d
Days
Class 2
Risk

K082031 is an FDA 510(k) clearance for the APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Appasamy Associates (Arumbakkam, Chennai, IN). The FDA issued a Cleared decision on July 31, 2008 after a review of 14 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 Appasamy Associates devices

Submission Details

510(k) Number K082031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2008
Decision Date July 31, 2008
Days to Decision 14 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 110d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 107
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K082031.
VISUREF 600
K253834 · Carl Zeiss Vision GmbH · Mar 2026
HP-OCT (HP-OCT)
K231760 · Cylite Pty. , Ltd. · Mar 2024
Kowa SL-19
K222372 · Kowa Company , Ltd. · Nov 2022
MiiS Horus Eye Anterior Camera
K193188 · Medimaging Integrated Solution, Inc (Miis) · Jan 2020
Sunkingdom Slit Lamp
K182306 · Chongqing Sunkingdom Medical Instrument Co., Ltd. · Nov 2018
IOLMaster 700
K173771 · Carl Zeiss Meditec, AG · Aug 2018