Digital Visual Acuity Test
FDA product code QTO
A Digital Visual Acuity Test is an FDA Class 1 Ophthalmic device (21 CFR 886.1150) used to measure how clearly a patient can see.
- Read the committed 2026-09-16 QTO snapshot (33 registrations).
- Classify each registration as "makes this device" or "does not" from the establishment-type sentences. Makes this device: Manufacturer and Contract manufacturer. Does not: Specification developer, Complaint-file holder, Private-label distributor, Exporter to the US, Repackager / relabeler. A registration that holds both kinds counts as "makes this device".
- 27 manufacture the device. 16 of those are in the United States. 5 of those 16 are in California. The other 6 do not manufacture.
33 companies in 9 countries are registered to make or handle this device.
- Roles: Manufacturer 26 · Contract manufacturer 2 · Specification developer 4 · Complaint-file holder 7 · Private-label distributor 1 · Exporter to the US 2 · Repackager / relabeler 1
- Countries: United States 19 · China 4 · Canada 2 · France 2 · India 2 · Israel 1 · Italy 1 · Türkiye 1 · United Kingdom 1
Registered companies
Manufacturer · 21
123 SEE
Boston, MA, United States
1800 CONTACTS, INC
Draper, UT, United States
6over6 Vision Ltd
Tel Aviv, Israel
ADAPTIVE SENSORY TECHNOLOGY INC
San Diego, CA, United States
AKRITI OPHTHALMIC PRIVATE LIMITED
Hyderabad Telangana, India
AMA OPTICS, INC.
Miami Beach, FL, United States
CKVULPECULAE, LLC
San Diego, CA, United States
DIAGNOSYS LLC
Lowell, MA, United States
EYEQUE CORPORATION
Newark, CA, United States
GOME OPTICAL LENS COMPANY LIMITED
Yonkers, NY, United States
GREENS SURGICALS PRIVATE LIMITED
Vadodara Gujar?t, India
HEDGEFOG RESEARCH INC.
San Pedro, CA, United States
LANGFANG FAR EAST PROSPEROUS OPTICAL INSTRUMENT CO.,LTD.
Langfang Hebei, China
M&S TECHNOLOGIES
Thayne, WY, United States
OCULERA SAGLIK TEKNOLOJILERI A.S.
ANKARA, Türkiye
Polinelli S.r.l.
Daverio Varese, Italy
RETINALOGIK INC.
Calgary Alberta, Canada
TILAK HEALTHCARE
Paris 11e Arrondissement Paris, France
VISIBLY
Wilmington, DE, United States
New York, NY, United States
eyeMobil Innovations
Benton Harbor, MI, United States
Contract manufacturer · 1
RMF Design and Manufacturing Inc.
Mississauga Ontario, Canada
Specification developer · 3
EYECHEQ, INC
Miami, FL, United States
Miami, FL, United States
KYS Vision, Inc.
Elko, NV, United States
Complaint-file holder · 4
M&S TECHNOLOGIES
NILES, IL, United States
MEDNEUROPTEK INC.
Johns Creek, GA, United States
MICRO MEDICAL DEVICES, INC.
Calabasas, CA, United States
OKULO LIMITED
Bristol, UK, Bristol, City of, United Kingdom
Private-label distributor · 1
BEIJING HONGDEE CORPORATION
Beijing, China
Exporter to the US · 2
ESSILOR INTERNATIONAL
CRETEIL Val-de-Marne, France
Fabris Lane Eyewear (Wenzhou) LTD
Wenzhou Zhejiang, China
Repackager / relabeler · 1
Guangzhou Four E's Scientific Co., Ltd.
GUANGZHOU Guangdong, China
Source: U.S. FDA device registration & listing data (openFDA), snapshot 2026-09-16. Seed demo covering one product code.