Atlas FDA

WAVELIGHT FS200 LASER SYSTEM MODEL: FS200

FDA 510(k) clearance K101006 · decided 2010-10-21

Clearance details

K-number
K101006
Device name
WAVELIGHT FS200 LASER SYSTEM MODEL: FS200
Applicant
Alcon Research, Ltd.
Decision
Substantially Equivalent
Date received
2010-04-12
Decision date
2010-10-21
Days to decision
192 days
Clearance type
Traditional
Product code
GEX
Device class
2
Regulation number
878.4810
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Fort Worth, TX, US
Third-party review
No
Expedited review
No

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