The following data is part of a premarket notification filed by Hiossen, Inc. with the FDA for Is3.
| Device ID | K180527 |
| 510k Number | K180527 |
| Device Name: | IS3 |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | Hiossen, Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| Contact | David Kim |
| Correspondent | David Kim Hiossen, Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-28 |
| Decision Date | 2018-05-16 |
| Summary: | summary |