Atlas FDA

LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML

FDA 510(k) clearance K003031 · decided 2001-01-05

Clearance details

K-number
K003031
Device name
LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML
Applicant
Alpha Vista, Inc.
Decision
Substantially Equivalent
Date received
2000-09-28
Decision date
2001-01-05
Days to decision
99 days
Clearance type
Traditional
Product code
LPN
Device class
2
Regulation number
886.5928
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Novata, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.