FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HARD CONTACT LENS REMOVER. ITEM #289
K Number: K872591
·
Decision Aug 4, 1987
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
11
Applicant Total
8
Review Days
34
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Basic Information
- Device Name
- HARD CONTACT LENS REMOVER. ITEM #289
- K Number
- K872591
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5420
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Magnivision, Inc.
- Date Received
- July 1, 1987
- Decision Date
- August 4, 1987
- Product Code
- KYE
- 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 |
|---|---|---|---|
| KYE | Inserter/Remover Contact Lens | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KYE), ordered by most recent decision date.
SOFT CONTACT LENS REMOVER
FDA 510(k)
FDA Class 1
·Ophthalmic
CONTACT LENS TWEEZERS
FDA 510(k)
FDA Class 1
·Ophthalmic
SUMMIT OPTICS CONTACT LENS REMOVER
FDA 510(k)
FDA Class 1
·Ophthalmic
MARLIN SOFT LENS TWEEZER
FDA 510(k)
FDA Class 1
·Ophthalmic
MARLIN SOFT LENS HANDLER
FDA 510(k)
FDA Class 1
·Ophthalmic
LENSERT CONTACT LENS CLEANING & INSERT
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Magnivision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K900777 | ITEM #273 CONTACT LENS CASES | Mar 30, 1990 | Substantially Equivalent |
| K900778 | ITEM #272 MAGNIF-EYES CONTACT LENS CASE | Mar 30, 1990 | Substantially Equivalent |
| K897085 | COMFEES(R) + CON-PAK(TM) LENS CASE | Feb 28, 1990 | Substantially Equivalent |
| K897084 | CONFEES(R)+ CONTACT LENS HOLDER | Feb 28, 1990 | Substantially Equivalent |
| K882384 | DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283 | Jun 23, 1989 | Substantially Equivalent |
| K890533 | ITEM #352/#CS352* CONTACT LENS CASES | Jun 23, 1989 | Substantially Equivalent |
| K872567 | SOFT CONTACT LENS REMOVER | Aug 10, 1987 | Substantially Equivalent |