The following data is part of a premarket notification filed by Sheaumann Laser, Inc with the FDA for Neolas.
| Device ID | K150664 |
| 510k Number | K150664 |
| Device Name: | NeoLas |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SHEAUMANN LASER, INC 45 Bartlett Street Marlborough, MA 01752 |
| Contact | Katina Sousa |
| Correspondent | Katina Sousa SHEAUMANN LASER, INC 45 Bartlett Street Marlborough, MA 01752 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-16 |
| Decision Date | 2015-12-22 |
| Summary: | summary |