Atlas FDA

AURIGA XL

FDA 510(k) clearance K111475 · decided 2011-09-28

Clearance details

K-number
K111475
Device name
AURIGA XL
Applicant
Starmedtec GmbH
Decision
Substantially Equivalent
Date received
2011-05-27
Decision date
2011-09-28
Days to decision
124 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
Starnberg, DE
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser recall (Z-1391-2019)Boston Scientific Corporation2019-05-22
AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser S recall (Z-1392-2019)Boston Scientific Corporation2019-05-22
AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL 4007 recall (Z-1393-2019)Boston Scientific Corporation2019-05-22
AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: The Auriga XL 4007 recall (Z-1394-2019)Boston Scientific Corporation2019-05-22
AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and recall (Z-1395-2019)Boston Scientific Corporation2019-05-22
AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser recall (Z-1396-2019)Boston Scientific Corporation2019-05-22
AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System an recall (Z-1397-2019)Boston Scientific Corporation2019-05-22
AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Auriga XL 4007 Laser S recall (Z-1398-2019)Boston Scientific Corporation2019-05-22
AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007 Lase recall (Z-1399-2019)Boston Scientific Corporation2019-05-22
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical recall (Z-0897-2018)Boston Scientific Corporation2018-03-05
Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in recall (Z-0898-2018)Boston Scientific Corporation2018-03-05
StarMedTec LightTrail Reusable Fibers, 365 um; Material/Part Number: 6453 recall (Z-0049-2015)Boston Scientific Corporation2014-10-08
StarMedTec LightTrail Reusable Fibers, 600 um; Material/Part Number: 6455 recall (Z-0050-2015)Boston Scientific Corporation2014-10-08
StarMedTec LightTrail Reusable Fibers, 800 um; Material/Part Number: 6457 recall (Z-0051-2015)Boston Scientific Corporation2014-10-08