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Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
NZY
Light, Lymphedema Reduction, Low Energy
2
Product Code
K
03
0295
LTU-904 PORTABLE LASER THERAPY UNIT
2
Cleared 510(K)
OAP
Laser, Comb, Hair
2
Product Code
OZC
Over The Counter Thermal Treatment For Acne.
2
Product Code
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 10 January 2025 at 11:05 pm
SU
/
subpart-f—physical-medicine-therapeutic-devices
/
NZY
/
K030295
View Source
LTU-904 PORTABLE LASER THERAPY UNIT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K030295
510(k) Type
Traditional
Applicant
RIANCORP PTY LTD
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/23/2004
Days to Decision
695 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
NZY
Light, Lymphedema Reduction, Low Energy
K
03
0295
LTU-904 PORTABLE LASER THERAPY UNIT
OAP
Laser, Comb, Hair
OZC
Over The Counter Thermal Treatment For Acne.
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-f—physical-medicine-therapeutic-devices
/
NZY
/
K030295
View Source
LTU-904 PORTABLE LASER THERAPY UNIT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K030295
510(k) Type
Traditional
Applicant
RIANCORP PTY LTD
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/23/2004
Days to Decision
695 days
Submission Type
Summary