The following data is part of a premarket notification filed by Msq (m2) Ltd. with the FDA for Soprano Hair Removal Diode Laser.
| Device ID | K052874 |
| 510k Number | K052874 |
| Device Name: | SOPRANO HAIR REMOVAL DIODE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MSQ (M2) LTD. 7 HAESHEL ST. INDUSTRIAL PARK Caesarea, IL 38900 |
| Contact | Tatiana Epstein |
| Correspondent | Tatiana Epstein MSQ (M2) LTD. 7 HAESHEL ST. INDUSTRIAL PARK Caesarea, IL 38900 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-12 |
| Decision Date | 2005-11-22 |
| Summary: | summary |