510(k) K974724
- Device
- SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT
- Applicant
- LENS COMFORT, INC.
- 510(k) number
- K974724
- Product code
- LYL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-03-02
- Date received
- 1997-12-18
- Regulation
- 886.5928
- Classification name
- Accessories, Solution, Ultrasonic Cleaners For Lenses
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES C DEMESTICHAS
- Address
- 912 Broad St. Elizabeth NJ US 07208 07208
FDA Registration Numbers#
- 1032500
- 2026940
- 1313525
Source Documents#
Other 510(k) Records For Product Code LYL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211361 | 3N Contact Lenses Adjunct Cleaner | Suzhou 3N Biological Technology Co., Ltd. | 2022-01-13 |
| K210300 | VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System | Vuesonic, LLC | 2021-04-01 |
| K083757 | BPZ02 MULTIPURPOSE SOLUTION | Bausch & Lomb, Inc. | 2009-11-18 |
| K021699 | AUTOLENS CLEANING AND DISINFECTING UNIT | Autolens, Inc. | 2002-12-16 |
| K022687 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | 2002-11-19 |
| K020802 | RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION | Bausch & Lomb, Incorporated | 2002-05-31 |
| K994021 | CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION | Strieter Clinical Research Laboratories, Inc. | 2000-02-22 |
| K991965 | PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES | Purilens, Inc. | 1999-10-01 |
| K982115 | LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY | Rim-Wide Companies, Inc. | 1999-01-13 |
| K964222 | ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING | Paladin Medical, Inc. | 1996-12-20 |
| K962112 | NEW COMFORT CONTACT LENS CARE ACCESSORY | Lens Comfort, Inc. | 1996-11-29 |
| K950940 | OPTI PADS | Karlen Mfg., Inc. | 1995-06-26 |
| K923816 | CONTACT LENS CLEANING ACCESSORY | Cramer Ent., Inc. | 1993-03-08 |
| K921615 | LENSONIC(TM) CONTACT LENS CARE ACCESSORY | Personal Professional Products, Inc. | 1992-11-05 |
| K921882 | THE CLEANER ACCESSORY | Eaton Medical Corp. | 1992-08-25 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases