The following data is part of a premarket notification filed by Laserstim, Inc. with the FDA for Stimlase 2000 Low Level Laser Therapy System.
| Device ID | K123177 |
| 510k Number | K123177 |
| Device Name: | STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | LASERSTIM, INC. 8708 CAPEHART COVE Austin, TX 78733 |
| Contact | David C Furr |
| Correspondent | David C Furr LASERSTIM, INC. 8708 CAPEHART COVE Austin, TX 78733 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-09 |
| Decision Date | 2013-07-03 |
| Summary: | summary |