510(k) K011718
K011718 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT". The FDA issued a decision of Substantially Equivalent on July 25, 2001. 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
- July 25, 2001
- Date Received
- June 4, 2001
- Clearance Type
- Traditional
- 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