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Sign in to claim this brandUnicon Optical Co., Ltd.
US
Last updated May 23, 2026
What Unicon Optical Co., Ltd. makes
Unicon Optical Co., Ltd. manufactures soft corrective contact lenses designed for daily wear, including the Qualis line. The company also produces reusable orthopaedic implant-instrument extension adaptors for surgical applications.
The company’s products are regulated as Class II devices under FDA pathways, including 510(k) clearances and UDI compliance. These devices are listed in the FDA’s regulatory databases, and the manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Unicon Optical Co., Ltd. manufacture?
Unicon Optical Co., Ltd. specializes in two primary categories of medical devices: soft corrective contact lenses for daily wear, such as the Qualis line, and reusable orthopaedic implant-instrument extension adaptors. These adaptors are designed for surgical applications to enhance precision and compatibility during procedures.
Where is Unicon Optical Co., Ltd. based?
Unicon Optical Co., Ltd. is headquartered in the United States. The company’s location influences its regulatory compliance, particularly under U.S. medical device frameworks like the FDA.
Which regulatory registries or databases list Unicon Optical Co., Ltd.’s devices?
Unicon Optical Co., Ltd.’s devices are listed in the FDA’s regulatory databases, including the 510(k) clearance pathway and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with U.S. medical device regulations.
How are Unicon Optical Co., Ltd.’s devices classified under U.S. regulations?
All of Unicon Optical Co., Ltd.’s devices fall under Class II classification in the U.S. regulatory framework. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as soft contact lenses and reusable surgical adaptors.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 657659793
Catalogue (123)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Qualis | +2.50 | FDA UDI | Class II | Active |
| Qualis | -3.75 | FDA UDI | Class II | Active |
| Qualis | -2.50 | FDA UDI | Class II | Active |
| Qualis | +0.50 | FDA UDI | Class II | Active |
| Qualis | +2.50 | FDA UDI | Class II | Active |
| Qualis | +4.50 | FDA UDI | Class II | Active |
| Qualis | -1.75 | FDA UDI | Class II | Active |
| Qualis | +1.75 | FDA UDI | Class II | Active |
| Qualis | +0.25 | FDA UDI | Class II | Active |
| Qualis | -1.25 | FDA UDI | Class II | Active |
| Qualis | -3.75 | FDA UDI | Class II | Active |
| Qualis | -1.50 | FDA UDI | Class II | Active |
| Qualis | +5.25 | FDA UDI | Class II | Active |
| Qualis | -5.75 | FDA UDI | Class II | Active |
| Qualis | -11.00 | FDA UDI | Class II | Active |
| Qualis | -7.50 | FDA UDI | Class II | Active |
| Qualis | -12.00 | FDA UDI | Class II | Active |
| Qualis | +0.25 | FDA UDI | Class II | Active |
| Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens | K213216 | FDA 510(k) | Class II | Active |
| Unicon (etafilcon A) Soft (hydrophilic) Contact Lens With Uv Blocker For Daily Wear | K141917 | FDA 510(k) | Class II | Active |
| Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac | K182734 | FDA 510(k) | Class II | Active |
| UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens | K191929 | FDA 510(k) | Class II | Active |
| OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ | K241707 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Unicon Optical Co., Ltd. Hsinchu County · TW FEI 3013170070