Cleared Traditional

K093021 - ATLANTIS SLIT LAMP

K093021 is an FDA 510(k) clearance for ATLANTIS SLIT LAMP, manufactured by Us Opthalmic, LLC. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K093021 · Us Opthalmic, LLC · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
121d
Days
Class 2
Risk

K093021 is an FDA 510(k) clearance for the ATLANTIS SLIT LAMP. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Us Opthalmic, LLC (Miami, US). The FDA issued a Cleared decision on January 28, 2010 after a review of 121 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K093021

510(k) Number K093021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2009
Decision Date January 28, 2010
Days to Decision 121 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
11d slower than avg
Panel avg: 110d · This submission: 121d
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 K093021.
MEDIWORKS SLIT LAMP
K100439 · Shanghai Mediworks Precision Instruments Co. , Ltd. · Jul 2010
SLIT LAMP BO 900, BQ 900, BP900
K100202 · Haag-Streit AG · Mar 2010
PSL CLASSIC SLIT LAMP
K100500 · Keeler Instruments, Inc. · Mar 2010
LED LAMP OR OTHER
K092883 · Intravista Medical Systems, Inc. · Dec 2009
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
K093021 · ATLANTIS SLIT LAMP
Download PDF FDA Summary Us Opthalmic, LLC