Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K002649 |
Device Name |
ARAMIS DERMATOLOGICAL LASER |
Applicant |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
131 KELEKENT LN. |
CARY,
NC
27511
|
|
Applicant Contact |
Marcy Moore |
Correspondent |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
131 KELEKENT LN. |
CARY,
NC
27511
|
|
Correspondent Contact |
Marcy Moore |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 08/24/2000 |
Decision Date | 11/21/2000 |
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
|