Cleared Traditional

K100595 - ECLERIS MICROSTAR COLPOSCOPE

K100595 is an FDA 510(k) clearance for ECLERIS MICROSTAR COLPOSCOPE, manufactured by Ecleris USA. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K100595 · Ecleris USA · Obstetrics & Gynecology device
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Jul 2010
Decision
129d
Days
Class 2
Risk

K100595 is an FDA 510(k) clearance for the ECLERIS MICROSTAR COLPOSCOPE. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Ecleris USA (San Diego, US). The FDA issued a Cleared decision on July 9, 2010 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1630 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ecleris USA devices

FDA 510(k) Submission Details - K100595

510(k) Number K100595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2010
Decision Date July 09, 2010
Days to Decision 129 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 161d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEX Device Classification - Class 2, Special Controls

Product Code HEX Colposcope (and Colpomicroscope)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1630
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HEX Colposcope (and Colpomicroscope)

All 41
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K100595.
DYSIS
K092433 · Forth Photonics Hellas SA · Mar 2011
ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY
K090324 · Sti Medical Systems · Dec 2010
SEILER COLPOSCOPE, MODELS 935, 955 AND 985
K101141 · Seiler Precision Microscopes · Aug 2010
CERVICAL MD, MODEL C10
K072691 · Sti Medical Systems · Jan 2008
COLPO-MASTER
K073053 · United Products & Instruments, Inc. · Nov 2007
SOUNMED COLOPOSCOPE COLPO-99/99PLUS
K070845 · Sounmed, Inc. · Oct 2007