Data / Medical devices / Shell, Scleral
Shell, Scleral (HQT): 11 FDA-registered makers in 2 countries
11 establishments in 2 countries are registered with the FDA to make Shell, Scleral (product code HQT, Class 2, 21 CFR 886.3800). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on July 7, 1997, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HQT
- Device class
- 2
- Regulation
- 886.3800
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| India | 3 |
Makers of Shell, Scleral
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Accutome, Inc. | Malvern, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Akriti Ophthalmic Private Limited | Hyderabad Telangana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dallas Eye Prosthetics | Dallas, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lights' Prosthetic Eyes, Inc. | Peoria, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Eye Laboratories Sioux Falls LLC | Sioux Falls, SD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Eye Laboratories Woodbury LLC | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Eye Laboratories, Inc. | Rochester, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Eye Laboratories, Inc. | Eau Claire, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Soper Brothers & Associates | Houston, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Speedway | India Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 7, 1997. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.