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
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97
Medical Genetics
8
Microbiology
466
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965
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433
Ophthalmic
274
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2886
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52
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515
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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.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 21, 2023
Biophotas Celluma CONTOUR
K232977
·
OLI
General & Plastic Surgery
·
61d
Cleared
Jun 29, 2021
Biophotas Celluma RESTORE
K211038
·
OAP
General & Plastic Surgery
·
83d
Cleared
Sep 01, 2017
BIOPHOTAS CELLUMA3
K171323
·
OHS
General & Plastic Surgery
·
119d
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6
Physical Medicine
3
General & Plastic Surgery
3