AQUAFLEX 2 (TEFILCON) CONTACT LENS
FDA 510(k) clearance K050743 · decided 2005-04-13
Clearance details
- K-number
- K050743
- Device name
- AQUAFLEX 2 (TEFILCON) CONTACT LENS
- Applicant
- Unilens Corp., USA
- Decision
- Substantially Equivalent
- Date received
- 2005-03-21
- Decision date
- 2005-04-13
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Largo, FL, 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 |
|---|---|---|
| SOFT-FORM 55EW; LL-55; SOFTCON EW2 (P890040/S008) | Unilens Corp., USA | 2016-02-29 |
| SOF-FORM 55 EW, LL-55, SOFTCON EW 2 (P890040/S007) | Unilens Corp., USA | 2013-08-06 |
| SOF-FORM 55 EW AND LL-55 SOFT HYDROPHILIC SPHERICAL CONTACT LENSES (P890040/S006) | Unilens Corp., USA | 2008-03-03 |
| SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P890040/S005) | Unilens Corp., USA | 2000-03-23 |
| UNILENS (HEFILCON A) CONTACT LENS (P850002/S008) | Unilens Corp., USA | 1993-11-17 |
| SIMULVUE (HEFILCON A) BIFOCAL CONTACT LENS (P850002/S009) | Unilens Corp., USA | 1993-11-17 |
| SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS (P890040/S004) | Unilens Corp., USA | 1992-06-29 |
| ALGES(TM) (HEFILCON A) CONTACT LENS (P850002/S007) | Unilens Corp., USA | 1991-08-28 |