Device Classification Name |
Laser, Ophthalmic
|
510(k) Number |
K081774 |
Device Name |
SOLX 790 TITANIUM SAPPHIRE LASER |
Applicant |
SOLX INC. |
890 WINTER ST., SUITE 115 |
WALTHAM,
MA
02451
|
|
Applicant Contact |
DOUG ADAMS |
Correspondent |
SOLX INC. |
890 WINTER ST., SUITE 115 |
WALTHAM,
MA
02451
|
|
Correspondent Contact |
DOUG ADAMS |
Regulation Number | 886.4390
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/23/2008 |
Decision Date | 09/12/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|