510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1663
Chemistry
362
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1334
Ear, Nose, Throat
244
Gastroenterology & Urology
963
General & Plastic Surgery
2184
General Hospital
2043
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126
Immunology
97
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8
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466
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963
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433
Ophthalmic
274
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2875
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52
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515
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2430
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
383
FXX
Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Freedom Laser Therapy, Inc.
Medical Device Manufacturer
·
US , Los Angeles , CA
Freedom Laser Therapy, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2016
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Freedom Laser Therapy, Inc.
General & Plastic Surgery
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 13, 2022
ID-510 iRestore Elite
K222081
·
OAP
General & Plastic Surgery
·
90d
Cleared
Dec 22, 2021
ID-500 iRestore Hair Growth System
K213094
·
OAP
General & Plastic Surgery
·
89d
Cleared
May 17, 2019
iRestore Professional 282
K183417
·
OAP
General & Plastic Surgery
·
158d
Cleared
Jan 06, 2016
iRestore
K151662
·
OAP
General & Plastic Surgery
·
201d
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4
General & Plastic Surgery
4