Atlas FDA

DENLASER, MODEL 800

FDA 510(k) clearance K003541 · decided 2001-01-25

Clearance details

K-number
K003541
Device name
DENLASER, MODEL 800
Applicant
CAO Group, Inc.
Decision
Substantially Equivalent
Date received
2000-11-16
Decision date
2001-01-25
Days to decision
70 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
Sandy, UT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, Manufactured by Siemens Medical recall (Z-0246-2008)Siemens Medical Solutions USA Inc2008-01-04
Biograph 40 - 3 Ring, Biograph PET/CT Scanner, Catalog No. 10097233, Manufactured by Sieme recall (Z-0247-2008)Siemens Medical Solutions USA Inc2008-01-04
Biograph 40 TruePoint, Biograph PET/CT Scanner, Catalog No. 10097303, Manufactured by Siem recall (Z-0248-2008)Siemens Medical Solutions USA Inc2008-01-04
Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728854, Manufactured by Siemens Medical recall (Z-0249-2008)Siemens Medical Solutions USA Inc2008-01-04
Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728573, Manufactured by Siemens Medical recall (Z-0250-2008)Siemens Medical Solutions USA Inc2008-01-04
Biograph 64-3 Ring, Biograph PET/CT Scanner, Catalog No. 8727450, Manufactured by Siemens recall (Z-0251-2008)Siemens Medical Solutions USA Inc2008-01-04
Biograph DUO LSO, Biograph PET/CT Scanner, Catalog No. 8728813, Manufactured by Siemens Me recall (Z-0252-2008)Siemens Medical Solutions USA Inc2008-01-04
Siemens ECAT ACCEL, Catalog No. 3554479, PET/CT Scanner, Manufactured by Siemens Medical S recall (Z-0269-2008)Siemens Medical Solutions USA Inc2007-11-29
Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Manufactured by Siemens Medical So recall (Z-0270-2008)Siemens Medical Solutions USA Inc2007-11-29
Siemens ECAT EXACT 47, Catalog No. 1788772, PET/CT Scanner, Manufactured by Siemens Medica recall (Z-0271-2008)Siemens Medical Solutions USA Inc2007-11-29
Siemens ECAT EXACT HR 47, Catalog No. 2956261, PET/CT Scanner, Manufactured by Siemens Med recall (Z-0272-2008)Siemens Medical Solutions USA Inc2007-11-29
Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner, Manufactured by Siemens Medic recall (Z-0273-2008)Siemens Medical Solutions USA Inc2007-11-29