BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
FDA 510(k) clearance K091339 · decided 2010-01-05
Clearance details
- K-number
- K091339
- Device name
- BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
- Applicant
- CooperVision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-05-06
- Decision date
- 2010-01-05
- Days to decision
- 244 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
+ Add to Predicate Builder ◉ Watch CooperVision
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmati recall (Z-0543-2014) | CooperVision Inc. | 2013-12-19 |