Device Classification Name |
powered laser surgical instrument with microbeam\fractional output
|
510(k) Number |
K101490 |
Device Name |
FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US |
Applicant |
THERMAGE, INC. |
25881 INDUSTRIAL BLVD. |
HAYWARD,
CA
94545
|
|
Applicant Contact |
KRISS FOSS |
Correspondent |
THERMAGE, INC. |
25881 INDUSTRIAL BLVD. |
HAYWARD,
CA
94545
|
|
Correspondent Contact |
KRISS FOSS |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 06/01/2010 |
Decision Date | 09/08/2010 |
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
|
Recalls |
CDRH Recalls
|