FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
K Number: K213216
·
Decision Jan 18, 2022
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
5
Review Days
111
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Basic Information
- Device Name
- Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
- K Number
- K213216
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Unicon Optical Co., Ltd.
- Date Received
- September 29, 2021
- Decision Date
- January 18, 2022
- Product Code
- LPL
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | FDA class 2 | Ophthalmic |
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Other Clearances by Unicon Optical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K241707 | OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL | Jul 12, 2024 | Substantially Equivalent |
| K191929 | UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens | Sep 17, 2019 | Substantially Equivalent |
| K182734 | Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac | May 16, 2019 | Substantially Equivalent |
| K141917 | UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR | Oct 17, 2014 | Substantially Equivalent |