Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K121471 |
Device Name |
LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS |
Applicant |
LIGHTSCALPEL LLC |
16932 WOOD-RED RD NE STE 201 |
WOODINVILLE,
WA
98072
|
|
Applicant Contact |
GERALD S PALECKI |
Correspondent |
LIGHTSCALPEL LLC |
16932 WOOD-RED RD NE STE 201 |
WOODINVILLE,
WA
98072
|
|
Correspondent Contact |
GERALD S PALECKI |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 05/18/2012 |
Decision Date | 07/10/2012 |
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
|