Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K990075 |
Device Name |
LPULSA SYL-9000 OPHTHALMIC YAG LASER |
Applicant |
LIGHT-MED (USA), INC. |
110P VIA ESTRADA |
LAGUNA HILLS,
CA
92653
|
|
Applicant Contact |
THOMAS V KEELEY |
Correspondent |
LIGHT-MED (USA), INC. |
110P VIA ESTRADA |
LAGUNA HILLS,
CA
92653
|
|
Correspondent Contact |
THOMAS V KEELEY |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 01/11/1999 |
Decision Date | 03/30/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|