Intelliwave4
FDA 510(k) clearance K142641 · decided 2015-01-12
Clearance details
- K-number
- K142641
- Device name
- Intelliwave4
- Applicant
- Art Optical Contact Lens, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-09-17
- Decision date
- 2015-01-12
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Art Optical Contact Lens
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
No recalls on record reference this clearance.