| Device Classification Name |
Powered Laser Surgical Instrument
|
|---|
| 510(k) Number |
K170734 |
|---|
| Device Name |
Venus Silk.expert |
|---|
| Applicant |
| Cyden Limited |
| Technium 2, Kings Rd., The Docks |
|
Swansea,
GB
Sa1 8pJ
|
|
| Applicant Contact |
Mike Kiernan |
| Correspondent |
| Cyden Limited |
| Technium 2, Kings Rd., The Docks |
|
Swansea,
GB
Sa1 8pJ
|
|
| Correspondent Contact |
Mike Kiernan |
| Regulation Number | 878.4810 |
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 03/10/2017 |
|---|
| Decision Date | 05/08/2017 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
General & Plastic Surgery
|
|---|
| 510k Review Panel |
General & Plastic Surgery
|
|---|
| Statement |
Statement
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|