Atlas FDA

NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI

FDA 510(k) clearance K111493 · decided 2011-07-27

Clearance details

K-number
K111493
Device name
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
Applicant
Nidek Co., Ltd.
Decision
Substantially Equivalent
Date received
2011-05-31
Decision date
2011-07-27
Days to decision
57 days
Clearance type
Traditional
Product code
HQB
Device class
2
Regulation number
886.4690
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Sunnyvale, CA, 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
Nidek EC-5000 Excimer Laser System (P970053/S017)Nidek Co., Ltd.2018-01-12
EC-5000 EXCIMER LASER SYSTEM (P970053/S016)Nidek Co., Ltd.2017-06-08
NIDEK EXCLAIMER LASER SYSTEM EC-5000 (P970053/S015)Nidek Co., Ltd.2015-03-30
NIDEK EXCIMER LASER SYSTEM EC-5000 (P970053/S013)Nidek Co., Ltd.2014-11-21
NIDEK EXCIMER LASER SYSTEM EC-5000 (P970053/S014)Nidek Co., Ltd.2014-11-14
NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM (P970053/S011)Nidek Co., Ltd.2013-09-30
NIDEK EC-5000 EXCIMER LASER SYSTEM (P970053/S012)Nidek Co., Ltd.2012-12-12
NIDEK EC-5000 EXCIMER LASER (P970053/S010)Nidek Co., Ltd.2006-11-08