Device Classification Name |
powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
|
510(k) Number |
K010175 |
Device Name |
MICROLIGHT 830 LASER SYSTEM |
Applicant |
MICROLIGHT CORPORATION OF AMERICA |
2935 HIGHLAND LAKES |
MISSOURI CITY,
TX
77459
|
|
Applicant Contact |
MICHAEL BARBOUR |
Correspondent |
MICROLIGHT CORPORATION OF AMERICA |
2935 HIGHLAND LAKES |
MISSOURI CITY,
TX
77459
|
|
Correspondent Contact |
MICHAEL BARBOUR |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 01/18/2001 |
Decision Date | 02/06/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|