Atlas FDA

THE CLEANER ACCESSORY

FDA 510(k) clearance K921882 · decided 1992-08-25

Clearance details

K-number
K921882
Device name
THE CLEANER ACCESSORY
Applicant
Eaton Medical Corp.
Decision
Substantially Equivalent
Date received
1992-04-21
Decision date
1992-08-25
Days to decision
126 days
Clearance type
Traditional
Product code
LYL
Device class
2
Regulation number
886.5928
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Memphis, TN, US
Third-party review
No
Expedited review
No

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RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION (K020802)Bausch & Lomb, Incorporated2002-05-31
CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION (K994021)Strieter Clinical Research Laboratories, Inc.2000-02-22
PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES (K991965)Purilens, Inc.1999-10-01
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
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
EASY EYES (TM) (P830009/S008)Eaton Medical Corp.1988-03-23
EASY EYES (TM) (P830009/S007)Eaton Medical Corp.1985-04-23
EASY EYES (TM) (P830009/S006)Eaton Medical Corp.1985-04-23
EASY EYES (TM) (P830009/S004)Eaton Medical Corp.1984-08-10
EASY EYES (TM) (P830009/S003)Eaton Medical Corp.1984-05-15
EASY EYES (TM) (P830009/S005)Eaton Medical Corp.1984-03-15
EASY EYES (TM) (P830009/S001)Eaton Medical Corp.1984-02-08
EASY EYES (TM) (P830009/S002)Eaton Medical Corp.1983-11-17