Pocket III

Pocket III is a handheld ultrasonic pachymeter for measuring corneal thickness in ophthalmology. Doctors or other appropriately trained healthcare professionals use the pen-shaped device in…

Registry build 21.09.26

Pocket III is a handheld ultrasonic pachymeter for measuring corneal thickness in ophthalmology. Doctors or other appropriately trained healthcare professionals use the pen-shaped device in healthcare institutions.

Its integrated 30 MHz probe contacts the corneal surface and sends ultrasound pulses through it. Echoes return from the anterior and posterior surfaces of the cornea, providing the signals used for the thickness measurement. The result appears numerically on an LCD display.

Listed Item

The POCKET III unit is an ultrasonic pachymeter intended to be used for the measurement of corneal thickness by ultrasonic means. This measurement is required for refractive surgery and for the diagnosis of glaucoma.

Data Transfer

Measurements can be exported to a computer using a USB-C cable connection or Bluetooth. The device is intended for corneal pachymetry and is not intended for fetal use.

37manufacturers in China registered for this device type
1catalogue number
8510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (14), Jiangsu (9), Shanghai (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IYO
Manufacturer City Province Registered as Device types
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Raise Medical Industries, Inc. Foshan Guangdong Contract manufacturer 16
ATL Technology DG,Ltd. Dongguan Guangdong Contract manufacturer 14
Xuzhou Yongkang Electronic Science Technology Co., Ltd. Xuzhou Jiangsu Contract manufacturer 13
Taijia Medical Electronics (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Philips Ultrasound (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 5
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56
Taizhou City K&W International Trade Co., Ltd. Jiangyan Jiangsu Repacker / relabeller 38
Contec Medical Systems Co., Ltd. Qinhuangdao Hebei Manufacturer 22
Sterigenics Shanghai E Beam Ltd. Shanghai Shanghai Contract manufacturer 14

Showing 12 of 37. All 37 manufacturers in China registered for System, Imaging, Pulsed Echo, Ultrasonic

Record

Regulatory record for Pocket III
Listed by Quantel Medical, France
FDA product code IYO
Device type System, Imaging, Pulsed Echo, Ultrasonic
Device class Class 2
Regulation 21 CFR 892.1560
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k) K232302
Record published 2025-03-25

Specifications

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

Catalogue Numbers

Catalogue numbers for Pocket III
Catalogue number Size Status
POCKET III In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hitachi Hitachi, Ltd. 224
eTRAX™ Needle Civco Medical Instruments Co., Inc. 43
BladderScan® Verathon Inc. 38
Verza Guidance System Civco Medical Instruments Co., Inc. 37
Needle Guide Civco Medical Instruments Co., Inc. 34
Siui Shantou Institute OF Ultrasonic Instruments Co., Ltd. 34
Biopsy Bracket Civco Medical Instruments Co., Inc. 33
Tracking Bracket Starter Kit Civco Medical Instruments Co., Inc. 29
System, Imaging, Pulsed Echo, Ultrasonic GE Healthcare Japan Corporation 23
eTRAX™ Needle System Starter Kit Civco Medical Instruments Co., Inc. 20
Tracking Bracket Civco Medical Instruments Co., Inc. 19
Logiq GE Ultrasound Korea, Ltd. 18

Showing 12 of 805. All products under System, Imaging, Pulsed Echo, Ultrasonic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K232302 2024-04-26
K213254 2021-11-15
K183414 2019-03-20
K180265 2018-03-02
K051851 2005-08-03
K021683 2002-06-21
K993674 2000-07-13
K000554 2000-03-14

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer