510(k) K112192
K112192 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS". The FDA issued a decision of Substantially Equivalent on October 25, 2011. The device falls under product code MVN (Lens, Contact, (Disposable)), a Class II device regulated under 21 CFR 886.5925. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2011
- Date Received
- July 29, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Contact, (Disposable)
- Device Class
- Class II
- Regulation Number
- 886.5925
- Review Panel
- OP
- Submission Type