INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
FDA 510(k) clearance K073621 · decided 2008-07-03
Clearance details
- K-number
- K073621
- Device name
- INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
- Applicant
- Art Optical Contact Lens, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-12-26
- Decision date
- 2008-07-03
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Grand Junction, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Art Optical Contact Lens
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
No recalls on record reference this clearance.