Cleared Traditional

K000707 - LEICA COLPOSCOPE

K000707 is an FDA 510(k) clearance for LEICA COLPOSCOPE, manufactured by Leica Microscopy Systems , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K000707 · Leica Microscopy Systems , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
117d
Days
Class 2
Risk

K000707 is an FDA 510(k) clearance for the LEICA COLPOSCOPE. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Leica Microscopy Systems , Ltd. (Great Neck, US). The FDA issued a Cleared decision on June 27, 2000 after a review of 117 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.

FDA 510(k) Submission Details - K000707

510(k) Number K000707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2000
Decision Date June 27, 2000
Days to Decision 117 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 161d · This submission: 117d
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 55
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K000707.
GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000
K021153 · Goldway Us, Inc. · Feb 2003
DFV CPG COLPOSCOPE
K021854 · D.F. Vasconcellos S.A. · Oct 2002
MEDSCOPE
K001314 · All-Pro Imaging Corp. · Jul 2000
TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
K992544 · Circon Corp. · Oct 1999
LEISEGANG VIDEO COLPOSCOPE
K981958 · Netoptix Corp. · Oct 1998
COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM
K972630 · CooperSurgical, Inc. · Feb 1998
K000707 · LEICA COLPOSCOPE
Download PDF FDA Summary Leica Microscopy Syst…