The following data is part of a premarket notification filed by Hyper Photonics Srl with the FDA for Hypho Laser System.
| Device ID | K163449 |
| 510k Number | K163449 |
| Device Name: | HyPHo Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Hyper Photonics SRL Via Lecco 61 Vimercate Mb, IT 20871 |
| Contact | Isabella Carrer |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-12-08 |
| Decision Date | 2017-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04058784001092 | K163449 | 000 |
| 08051272101263 | K163449 | 000 |
| 08051272101218 | K163449 | 000 |
| 08051272101195 | K163449 | 000 |
| 08051272101171 | K163449 | 000 |
| 08051272101140 | K163449 | 000 |
| 08051272101119 | K163449 | 000 |
| 08051272101089 | K163449 | 000 |
| 08051272101058 | K163449 | 000 |