510(k) K974724
K974724 is an FDA 510(k) premarket notification submitted by Lens Comfort, Inc. for the device "SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT". The FDA issued a decision of Substantially Equivalent on March 2, 1998. The device falls under product code LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses), a Class II device regulated under 21 CFR 886.5928. Lens Comfort, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1998
- Date Received
- December 18, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Solution, Ultrasonic Cleaners For Lenses
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type