SOFT-55 DAILY WEAR CONTACT LENS
FDA 510(k) clearance K961428 · decided 1996-05-21
Clearance details
- K-number
- K961428
- Device name
- SOFT-55 DAILY WEAR CONTACT LENS
- Applicant
- Lombart Lenses, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-15
- Decision date
- 1996-05-21
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Norfolk, VA, 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 |
|---|---|---|
| LL-79 LIDOFILCON B (HYDROPHILIC) CONTACT LENS (P840031/S009) | Lombart Lenses, Ltd. | 1998-07-09 |
| FINISHED METHAFILCON A CONTACT LENSES (P890049/S004) | Lombart Lenses, Ltd. | 1998-05-29 |
| FINISHED METHAFILCON A CONTACT LENSES (P890049/S003) | Lombart Lenses, Ltd. | 1994-07-06 |
| LOMBART (POLYMACON)POLYMER BUTTONS & LATHE LL-38L (P880102/S002) | Lombart Lenses, Ltd. | 1993-05-05 |
| LOMBART (POLYMACON) SOFT CONTACT LENSES (P880102/S001) | Lombart Lenses, Ltd. | 1992-03-05 |
| FINISHED METHAFILCON A CONTACT LENSES (P890049/S002) | Lombart Lenses, Ltd. | 1991-07-19 |
| SAULFON PW-70 A&B (P840031/S008) | Lombart Lenses, Ltd. | 1989-12-19 |
| FINISHED METHAFILCON A CONTACT LENSES (P890049/S001) | Lombart Lenses, Ltd. | 1989-10-10 |