Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K042496 |
Device Name |
ADEPT ULTRALITE 532 LASER |
Applicant |
ADEPT MEDICAL CONCEPTS |
29816 AVENIDA DE LAS BANDERAS |
RANCHO SANTA MARGARITA,
CA
92688
|
|
Applicant Contact |
JERRY MCFARLAND |
Correspondent |
ADEPT MEDICAL CONCEPTS |
29816 AVENIDA DE LAS BANDERAS |
RANCHO SANTA MARGARITA,
CA
92688
|
|
Correspondent Contact |
JERRY MCFARLAND |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/14/2004 |
Decision Date | 11/02/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|