Who else makes this device?

Name: Retitrack
Brand: Retitrack

Retitrack · Monitor, Eye Movement → Ophthalmic

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

All of them in Jiangsu.

Chinese manufacturers registered for FDA product code HLL
Manufacturer	City	Province	Registered as	Device types
Taizhou City K&W International Trade Co., Ltd.	Jiangyan	Jiangsu	Repacker / relabeller	38
66 Vision Tech Co., Ltd.	Suzhou	Jiangsu	Private-label distributor	24

Record

Regulatory record for Retitrack
Listed by	C. Light Technologies, Inc., United States
FDA product code	HLL
Device type	Monitor, Eye Movement
Device class	Class 2
Regulation	21 CFR 886.1510
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Record published	2024-10-18
Record revised	2026-02-09 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	High-level Disinfectant
Prescription	Prescription only
Label carries	manufacturing date, serial number
Packaging	Case

Catalogue Numbers

Catalogue numbers for Retitrack
Catalogue number	Size	Status
CR1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Eli Ezer	U.S. Ophthalmic, L.L.C.	2
Saccadometer	Ober Consulting Sp. Z.O.O.	2

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K222484	2023-05-09

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.

Retitrack