Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K103118 |
Device Name |
REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR |
Applicant |
HOYA PHOTONICS, INC. |
1105 SUNSET CREEK LANE |
PLEASANTON,
CA
94566
|
|
Applicant Contact |
DONNA TEMPLEMAN |
Correspondent |
HOYA PHOTONICS, INC. |
1105 SUNSET CREEK LANE |
PLEASANTON,
CA
94566
|
|
Correspondent Contact |
DONNA TEMPLEMAN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 10/21/2010 |
Decision Date | 11/19/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|