Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K893630 |
Device Name |
CANDELA UPC LASER PHOTOCOAGULATOR |
Applicant |
CANDELA LASER CORP. |
530 BOSTON POST RD. |
WAYLAND,
MA
01778
|
|
Applicant Contact |
GEORGE CHO |
Correspondent |
CANDELA LASER CORP. |
530 BOSTON POST RD. |
WAYLAND,
MA
01778
|
|
Correspondent Contact |
GEORGE CHO |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 05/11/1989 |
Decision Date | 08/02/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|