Home / 510(k) Clearances / K962112

510(k) K962112

NEW COMFORT CONTACT LENS CARE ACCESSORY by Lens Comfort, Inc. — Product Code LYL

K962112 is an FDA 510(k) premarket notification submitted by Lens Comfort, Inc. for the device "NEW COMFORT CONTACT LENS CARE ACCESSORY". The FDA issued a decision of Substantially Equivalent on November 29, 1996. 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
November 29, 1996
Date Received
May 31, 1996
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

Other clearances by Lens Comfort, Inc.

  • K974724 — SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS (March 2, 1998)

Other clearances for product code LYL

  • K211361 — 3N Contact Lenses Adjunct Cleaner (January 13, 2022)
  • K210300 — VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Clean (April 1, 2021)
  • K083757 — BPZ02 MULTIPURPOSE SOLUTION (November 18, 2009)
  • K021699 — AUTOLENS CLEANING AND DISINFECTING UNIT (December 16, 2002)
  • K022687 — AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (November 19, 2002)
  • K020802 — RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION (May 31, 2002)
  • K994021 — CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION (February 22, 2000)
  • K991965 — PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES (October 1, 1999)
  • K982115 — LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY (January 13, 1999)
  • K974724 — SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS (March 2, 1998)

FDA data resources