Device Classification Name |
lamp, infrared, therapeutic heating
|
510(k) Number |
K122237 |
Device Name |
BIOPHOTAS LIFELIGHT |
Applicant |
BIOPHOTAS, INC. |
28241 CROWN VALLEY PARKWAY, SUITE 510(K) |
LAGUNA NIGUEL,
CA
92677
|
|
Applicant Contact |
SHEPARD G BENTLEY, RAC |
Correspondent |
BIOPHOTAS, INC. |
28241 CROWN VALLEY PARKWAY, SUITE 510(K) |
LAGUNA NIGUEL,
CA
92677
|
|
Correspondent Contact |
SHEPARD G BENTLEY, RAC |
Regulation Number | 890.5500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/26/2012 |
Decision Date | 01/03/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|