Cleared Traditional

K082031 - APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES

K082031 is an FDA 510(k) clearance for APPASAMY SLIT LAMP, manufactured by Appasamy Associates. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K082031 · Appasamy Associates · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K082031

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HJO Biomicroscope, Slit-lamp, Ac-powered

All 105
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K082031.
SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500
K093639 · Huvitz Co., Ltd. · Dec 2009
LENSTAR, MODEL LS900
K082891 · Haag-Streit AG · Oct 2009
GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72
K080776 · Us Ophthalmic, LLC · Sep 2008
CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)
K072861 · Acheve Technology, Inc. · Jun 2008
SLIT LAMP
K073190 · Huvitz Co., Ltd. · Jan 2008
ELLEX SLIT LAMP, MODEL 30XL
K063352 · Takagi Seiko Co., Ltd. · Mar 2007
K082031 · APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES
Download PDF FDA Summary Appasamy Associates