Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K950019 |
Device Name |
THERMOLASE LT-100 ND:YAG LASER HAIR REMOVAL SYSTEM; THERMOLASE LT-100;LT-100 |
Applicant |
THERMOLASE CORP. |
9550 DISTRIBUTION AVE. |
SAN DIEGO,
CA
92121 -2306
|
|
Applicant Contact |
KENNETH Y TANG |
Correspondent |
THERMOLASE CORP. |
9550 DISTRIBUTION AVE. |
SAN DIEGO,
CA
92121 -2306
|
|
Correspondent Contact |
KENNETH Y TANG |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 01/03/1995 |
Decision Date | 04/03/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|