What is FDA product code PTZ?

This product code is the class II exempt counterpart of HEX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.

Obstetrics & Gynecology › DiagnosticColposcope (And Colpomicroscope), Exempt

Optomic

Name: Optomic
Brand: Optomic

5 catalogue numbers from OP-C5 COLPOSCOPE, listed by Optomic España SA, under Colposcope (And Colpomicroscope), Exempt. 4 manufacturers in China are registered for this product code.

Registry build 21.09.26

4manufacturers in China registered for this device type

5catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1), Guangxi (1).

Chinese manufacturers registered for FDA product code PTZ
Manufacturer	City	Province	Registered as	Device types
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Zumax Medical Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
Alltion (Guangxi) Instrument Co., Ltd.	Wuzhou	Guangxi	Manufacturer	8
Shenzhen Goldcare Meditech Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	2

Record

Regulatory record for Optomic
Listed by	Optomic España SA
FDA product code	PTZ
Device type	Colposcope (And Colpomicroscope), Exempt
Device class	Class 2
Regulation	21 CFR 884.1630
Premarket notification	Exempt
Record published	2024-07-18

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Optomic
Catalogue number	Size	Status
OP-C5 COLPOSCOPE		In distribution
OP-C12 COLPOSCOPE (45)		In distribution
OP-C2 COLPOSCOPE		In distribution
OP-C16 COLPOSCOPE (45)		In distribution
OP-C2L COLPOSCOPE		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
UHD series Video Colposcope	Edan Instruments, Inc.	4
zumax	Zumax Medical Co., Ltd.	2
Atmos	Atmos Medizintechnik Gmbh & Co. KG	2
Video Colposcope	Edan Instruments, Inc.	1
Light guide	Olympus Medical Systems Corp.	1
Colposcope OCS-500 Digital Camera Adapter	Olympus Medical Systems Corp.	1
Colposcope OCS-500 System Rack	Olympus Medical Systems Corp.	1
Small tray	Olympus Medical Systems Corp.	1
Liger Medical	Liger Medical	1
Eyepiece shape TV mount	Olympus Medical Systems Corp.	1
Cerviray	Aidot	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.