OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR
FDA 510(k) clearance K003996 · decided 2001-02-21
Clearance details
- K-number
- K003996
- Device name
- OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR
- Applicant
- Ocu-Ease Optical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-26
- Decision date
- 2001-02-21
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Pinole, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PREFERRED PLUS 53 SOFT (HYDROPHILIC) ASPHERIC LENS (P820051/S015) | Ocu-Ease Optical Products, Inc. | 1993-02-26 |
| OCU-FLEX-53 SOFT CONTACT LENSES (P820051/S014) | Ocu-Ease Optical Products, Inc. | 1992-09-11 |
| STERILIZED FINISHED OCUFILCON B LENSES (P820051/S009) | Ocu-Ease Optical Products, Inc. | 1991-08-22 |
| CONTACT LENSES (P820051/S012) | Ocu-Ease Optical Products, Inc. | 1991-02-15 |
| STERILIZED FINISHED OCUFILCON B LENSES (P820051/S010) | Ocu-Ease Optical Products, Inc. | 1990-06-28 |
| STERILIZED FINISHED OCUFILCON B LENSES (P820051/S008) | Ocu-Ease Optical Products, Inc. | 1988-09-19 |
| OCU-FLEX (P820051/S003) | Ocu-Ease Optical Products, Inc. | 1986-09-29 |
| OCU-FLEX (P820051/S002) | Ocu-Ease Optical Products, Inc. | 1986-02-20 |