ACUVUE OASYS (senofilcon A) with Photochromic Additive
FDA 510(k) clearance K180299 · decided 2018-04-10
Clearance details
- K-number
- K180299
- Device name
- ACUVUE OASYS (senofilcon A) with Photochromic Additive
- Applicant
- Johnson & Johnson Vision Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-02-02
- Decision date
- 2018-04-10
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Jacksonville, 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 |
|---|---|---|
| LENEFILCON A HYDROPHILIC CONTACT LENSES (P990085/S001) | Johnson & Johnson Vision Care, Inc. | 2001-09-19 |
| VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P990085) | Johnson & Johnson Vision Care, Inc. | 2001-02-16 |