Laser Speckle Flowgraphy Lsfg-Navi

2 catalogue numbers from LSFG-NAVI-NM2, listed by Softcare Co., Ltd., Japan, under Ophthalmoscope, Ac-Powered. 7 manufacturers in China are registered for this product code.

Registry build 21.09.26
7manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (5), Beijing (1), Jiangxi (1).

Chinese manufacturers registered for FDA product code HLI
Manufacturer City Province Registered as Device types
Beijing Hongdee Corporation Beijing Beijing Private-label distributor 43
Lianyungang Tiannuo Optical Instrument Co., Ltd. Lianyungang Jiangsu Contract manufacturer 31
Shanghai Link Instruments Co., Ltd. Changzhou Jiangsu Manufacturer 21
Zumax Medical Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Raish Meditech Co., Ltd. Suzhou Jiangsu Manufacturer 4
Jiang XI BIG Vision Medical Technology Co., Ltd. Ganzhou Jiangxi Manufacturer 3
Robotrak Technologies Co., Ltd. Nanjing Jiangsu Manufacturer 1

Record

Regulatory record for Laser Speckle Flowgraphy Lsfg-Navi
Listed by Softcare Co., Ltd., Japan
FDA product code HLI
Device type Ophthalmoscope, Ac-Powered
Device class Class 2
Regulation 21 CFR 886.1570
Establishment Manufacturer
510(k) K153239
Record published 2018-02-19
Record revised 2026-04-13 (version 7)

Specifications

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

Catalogue Numbers

Catalogue numbers for Laser Speckle Flowgraphy Lsfg-Navi
Catalogue number Size Status
LSFG-NAVI-NM2 In distribution
LSFG-NAVI-NM2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Welch Allyn, Inc. Welch Allyn, Inc. 90
Amico Diagnostic Station Amico Diagnostic Incorporated 55
iVue Optovue, Inc. 27
Amico Diagnostic Wallboard Amico Diagnostic Incorporated 19
Amico Diagnostic Rollstand Amico Diagnostic Incorporated 14
iScan Optovue, Inc. 7
zumax Zumax Medical Co., Ltd. 6
Jedmed Jedmed Instrument Company 3
RTVue XR Avanti Optovue, Inc. 3
Amico Diagnostic Ophthalmoscope Amico Diagnostic Incorporated 3
Panoramic Ophthalmoscope Optos Public Limited Company 1
2.8v Specialist ophthalmoscope head & bulb Keeler Ltd. 1

Showing 12 of 46. All products under Ophthalmoscope, Ac-Powered

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