FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCU-FLEX-38 (POLYMACON)
K Number: K941998
·
Decision Oct 13, 1994
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
9
Review Days
171
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Basic Information
- Device Name
- OCU-FLEX-38 (POLYMACON)
- K Number
- K941998
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ocu-Ease Optical Products, Inc.
- Date Received
- April 25, 1994
- Decision Date
- October 13, 1994
- 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 Ocu-Ease Optical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023077 | OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT) | Dec 10, 2002 | Substantially Equivalent |
| K020690 | OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS | Apr 26, 2002 | Substantially Equivalent |
| K011577 | OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S | Jun 19, 2001 | Substantially Equivalent |
| K003996 | OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR | Feb 21, 2001 | Substantially Equivalent |
| K004000 | OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT | Feb 21, 2001 | Substantially Equivalent |
| K002966 | OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR | Nov 8, 2000 | Substantially Equivalent |
| K992466 | OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR | Oct 4, 1999 | Substantially Equivalent |
| K960291 | TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS | Mar 25, 1996 | Substantially Equivalent |