FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Contact Lens Case (multiple brand name)
K Number: K160005
·
Decision Jun 7, 2016
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
81
Applicant Total
1
Review Days
155
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Contact Lens Case (multiple brand name)
- K Number
- K160005
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Danyang Chanxin Glasses Cases Factory
- Date Received
- January 4, 2016
- Decision Date
- June 7, 2016
- Product Code
- LRX
- 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 |
|---|---|---|---|
| LRX | Case, Contact Lens | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRX), ordered by most recent decision date.
LANDR Contact LENS Case
FDA 510(k)
FDA Class 2
·Ophthalmic
MINI VP1 (PL67_F); MINI VP1 (PL61_F)
FDA 510(k)
FDA Class 2
·Ophthalmic
CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
FDA 510(k)
FDA Class 2
·Ophthalmic
Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)
FDA 510(k)
FDA Class 2
·Ophthalmic
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
FDA 510(k)
FDA Class 2
·Ophthalmic
Contact Lens Case, Model: A-1, B-1
FDA 510(k)
FDA Class 2
·Ophthalmic