Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K113709 |
Device Name |
MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE |
Applicant |
BIOLITEC MEDICAL DEVICES, INC |
1349 MAIN ROAD |
GRANVILLE,
MA
01034
|
|
Applicant Contact |
HARRY HAYES |
Correspondent |
BIOLITEC MEDICAL DEVICES, INC |
1349 MAIN ROAD |
GRANVILLE,
MA
01034
|
|
Correspondent Contact |
HARRY HAYES |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 12/19/2011 |
Decision Date | 01/20/2012 |
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
|