PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
FDA 510(k) clearance K991965 · decided 1999-10-01
Clearance details
- K-number
- K991965
- Device name
- PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
- Applicant
- Purilens, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-10
- Decision date
- 1999-10-01
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- LYL
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| 3N Contact Lenses Adjunct Cleaner (K211361) | Suzhou 3N Biological Technology Co., Ltd. | 2022-01-13 |
| VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System (K210300) | Vuesonic, LLC | 2021-04-01 |
| BPZ02 MULTIPURPOSE SOLUTION (K083757) | Bausch & Lomb, Inc. | 2009-11-18 |
| AUTOLENS CLEANING AND DISINFECTING UNIT (K021699) | Autolens, Inc. | 2002-12-16 |
| AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K022687) | Ciba Vision Corporation | 2002-11-19 |
| RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION (K020802) | Bausch & Lomb, Incorporated | 2002-05-31 |
| CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION (K994021) | Strieter Clinical Research Laboratories, Inc. | 2000-02-22 |
| LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY (K982115) | Rim-Wide Companies, Inc. | 1999-01-13 |
| SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT (K974724) | Lens Comfort, Inc. | 1998-03-02 |
| ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING (K964222) | Paladin Medical, Inc. | 1996-12-20 |
| NEW COMFORT CONTACT LENS CARE ACCESSORY (K962112) | Lens Comfort, Inc. | 1996-11-29 |
| OPTI PADS (K950940) | Karlen Mfg., Inc. | 1995-06-26 |
Recalls involving this device
No recalls on record reference this clearance.