Atlas FDA

Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc

FDA 510(k) clearance K173538 · decided 2017-12-04

Clearance details

K-number
K173538
Device name
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
Applicant
Alcon Laboratories, Inc.
Decision
Substantially Equivalent
Date received
2017-11-15
Decision date
2017-12-04
Days to decision
19 days
Clearance type
Special
Product code
LRX
Device class
2
Regulation number
886.5928
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Fort Worth, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S159)Alcon Laboratories, Inc.2025-12-12
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S158)Alcon Laboratories, Inc.2025-09-18
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S157)Alcon Laboratories, Inc.2025-08-25
AcrySof Posterior Chamber Intraocular Lenses and Delivery Systems (P930014/S152)Alcon Laboratories, Inc.2025-06-18
AcrySof Posterior Chamber Intraocular Lenses (P930014/S154)Alcon Laboratories, Inc.2025-03-21
WaveLight EX500 Laser (P020050/S043)Alcon Laboratories, Inc.2025-03-05
AcrySof Posterior Chamber Intraocular Lens (IOL) (P930014/S155)Alcon Laboratories, Inc.2025-02-14
AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S153)Alcon Laboratories, Inc.2025-02-04