Leisegang

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: LEISEGANG FDA UDI
Generic Name: Colposcope FDA UDI
Device Name: OPTIK Model 1 Colposcope; 3 MAG Non-Photo Upright Scope FDA UDI
Model / Reference: OPTIK1-01 FDA UDI
Description: OPTIK Model 1 Colposcope; 3 MAG Non-Photo Upright Scope FDA UDI

Identifiers

Primary DI / UDI-DI: 00888937013009 FDA UDI
510(k) Number: K140754 FDA UDI
FDA Product Code: HEX FDA UDI
GMDN Term: Colposcope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Colposcope

Leisegang by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Colposcope.

MICROSCOPE Colposcope — Ecleris · Class II
Bovie — BOVIE MEDICAL CORPORATION · Class II
Henry Schein — HENRY SCHEIN, INC. · Class II
MICROSTAR Colposcope — Ecleris · Class II
Gynex — GYNEX CORPORATION · Class II
MICROSCOPE Colposcope — Ecleris · Class II
Henry Schein — HENRY SCHEIN, INC. · Class II
Galileo Colposcope, Direct Access — GYNEX CORPORATION · Class II

Cleared under the same submission

K140754 also covers:

LEISEGANG — CooperSurgical, Inc.
LEISEGANG — CooperSurgical, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: CooperSurgical, Inc.

Sources (1)

FDA UDI 7a76e998-221d-422c-99c9-4f7eee206697 34 fields · synced Jun 9, 2026