Cleared Traditional

K060869 - RS-1000 ZOOM SLITLAMP WITH OPTION

K060869 is an FDA 510(k) clearance for RS-1000 ZOOM SLITLAMP WITH OPTION, manufactured by Rightmedical Products, LLC. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K060869 · Rightmedical Products, LLC · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
42d
Days
Class 2
Risk

K060869 is an FDA 510(k) clearance for the RS-1000 ZOOM SLITLAMP WITH OPTION. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Rightmedical Products, LLC (Virginia Beach, US). The FDA issued a Cleared decision on May 11, 2006 after a review of 42 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 - K060869

510(k) Number K060869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2006
Decision Date May 11, 2006
Days to Decision 42 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 110d · This submission: 42d
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 105
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K060869.
KOWA SL-15
K063640 · Kowa Co. , Ltd. · Dec 2006
LUXVISION SLIT LAMP
K063416 · Us Ophthalmic, LLC · Dec 2006
PSL PORTABLE SLIT LAMP
K061330 · Reichert, Inc. · May 2006
VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1
K043503 · Visx, Incorporated · Apr 2005
VISION-TECH YZ SLIT LAMP, MODEL 66
K033190 · Suzhou 66 Vision-Tech Co., Ltd. · Dec 2003
DOCUMENTING LASER SLIT LAMP, DP 2010
K012873 · Bausch & Lomb, Inc. · Nov 2001
K060869 · RS-1000 ZOOM SLITLAMP WITH OPTION
Download PDF FDA Summary Rightmedical Products…