Cleared Traditional

K862515 - BAUSCH & LOMB CSL-1000 SLIT LAMP

K862515 is an FDA 510(k) clearance for BAUSCH & LOMB CSL-1000 SLIT LAMP, manufactured by Bausch & Lomb, Inc.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K862515 · Bausch & Lomb, Inc. · Ophthalmic device
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Jul 1986
Decision
10d
Days
Class 2
Risk

K862515 is an FDA 510(k) clearance for the BAUSCH & LOMB CSL-1000 SLIT LAMP. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on July 11, 1986 after a review of 10 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 Bausch & Lomb, Inc. devices

FDA 510(k) Submission Details - K862515

510(k) Number K862515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1986
Decision Date July 11, 1986
Days to Decision 10 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 110d · This submission: 10d
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 51
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K862515.
WOODLYN CLASSIC SLIT LAMP MODEL SMM
K900477 · Woodlyn, Inc. · Feb 1990
ZEISS 40 SL/P PHOTO SLIT LAMP
K874160 · Carl Zeiss, Inc. · Jan 1988
OCS 100 (OCULAR COMPARATOR SYSTEM)
K874220 · Ocular Instruments, Inc. · Dec 1987
BAUSCH & LOMB OSL-2000 SLIT LAMP
K862516 · Bausch & Lomb, Inc. · Jul 1986
BAUSCH & LOMB PSL-3000 SLIT LAMP
K862520 · Bausch & Lomb, Inc. · Jul 1986
ZEISS 30 SL-L
K862004 · Carl Zeiss, Inc. · Jun 1986