Atlas FDA

MICRORUPTOR 6

FDA 510(k) clearance K160677 · decided 2017-05-19

Clearance details

K-number
K160677
Device name
MICRORUPTOR 6
Applicant
Meridian AG
Decision
Substantially Equivalent
Date received
2016-03-10
Decision date
2017-05-19
Days to decision
435 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
Thun, CH
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
LASAG MICRORUPTOR III Q-SWITCH ND:YAG (P840012/S007)Meridian AG1991-04-05
LASAG TOPAZ ND:YAG LASER SYSTEM (P840012/S006)Meridian AG1990-05-01
MICRORUPTOR MR-2 ND:YAG LASER SYSTEM (P840012/S005)Meridian AG1988-10-26
MICRORUPTOR MR-2 ND:YAG LASER SYSTEM (P840012/S003)Meridian AG1987-08-27
MICRORUPTOR MR-2 ND:YAG LASER SYSTEM (P840012/S002)Meridian AG1987-06-22
MICRORUPTOR MR-2 ND:YAG LASER SYSTEM (P840012/S001)Meridian AG1986-05-30
MICRORUPTOR MR-2 ND:YAG LASER SYSTEM (P840012)Meridian AG1986-01-31