The following data is part of a premarket notification filed by Msq (m2) Ltd. with the FDA for Mythos 500.
| Device ID | K030805 |
| 510k Number | K030805 |
| Device Name: | MYTHOS 500 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MSQ (M2) LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Contact | Arava Hacohen |
| Correspondent | Arava Hacohen MSQ (M2) LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-13 |
| Decision Date | 2003-05-21 |
| Summary: | summary |