Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K082586 |
FOIA Releasable 510(k) |
K082586
|
Device Name |
LIGHTWAVE PROFESSIONAL DELUXE |
Applicant |
LIGHTWAVE TECHNOLOGIES LLC |
55 Northern Blvd |
Suite 200 |
Great Neck,
NY
11021
|
|
Applicant Contact |
MARIA F GRIFFIN |
Correspondent |
LIGHTWAVE TECHNOLOGIES LLC |
55 Northern Blvd |
Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
MARIA F GRIFFIN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/08/2008 |
Decision Date | 01/04/2010 |
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
|