510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1666
Chemistry
362
Dental
1334
Ear, Nose, Throat
245
Gastroenterology & Urology
963
General & Plastic Surgery
2186
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2886
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52
Physical Medicine
515
Radiology
2431
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
384
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
353
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Biophotas, Inc.
Medical Device Manufacturer
·
US , Laguna Nuguel , CA
Biophotas, Inc. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2013
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biophotas, Inc.
Physical Medicine
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 02, 2016
BioPhotas Celluma3
K152280
·
ILY
Physical Medicine
·
203d
Cleared
Jan 15, 2014
BIOPHOTAS CELLUMA
K131113
·
ILY
Physical Medicine
·
268d
Cleared
Jan 03, 2013
BIOPHOTAS LIFELIGHT
K122237
·
ILY
Physical Medicine
·
161d
Filters
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6
Physical Medicine
3
General & Plastic Surgery
3