Cleared Traditional

K982057 - BC 900 SLIT LAMP

K982057 is an FDA 510(k) clearance for BC 900 SLIT LAMP, manufactured by Haag-Streit AG. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K982057 · Haag-Streit AG · Ophthalmic device
Download Printable Device Report (PDF)
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Aug 1998
Decision
64d
Days
Class 2
Risk

K982057 is an FDA 510(k) clearance for the BC 900 SLIT LAMP. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Haag-Streit AG (Koeniz, Bern, CH). The FDA issued a Cleared decision on August 14, 1998 after a review of 64 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 Haag-Streit AG devices

FDA 510(k) Submission Details - K982057

510(k) Number K982057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1998
Decision Date August 14, 1998
Days to Decision 64 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 110d · This submission: 64d
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 39
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K982057.
PSL CLASSIC SLIT LAMP
K100500 · Keeler Instruments, Inc. · Mar 2010
DOCUMENTING LASER SLIT LAMP, DP 2010
K012873 · Bausch & Lomb, Inc. · Nov 2001
IOLMASTER
K993357 · Carl Zeiss, Inc. · Mar 2000
KEELER TEARSCOPE-PLUS
K973064 · Keeler Instruments, Inc. · Apr 1998
NEITZ SLIT LAMP SL-H2
K951341 · Neitz Instruments Company, Ltd. · Jun 1995
NEITZ SLIT LAMP SL-H1
K951340 · Neitz Instruments Company, Ltd. · Apr 1995