The following data is part of a premarket notification filed by Future Device And Technology, Inc with the FDA for Gallieon-1 Medical Laser.
| Device ID | K132529 |
| 510k Number | K132529 |
| Device Name: | GALLIEON-1 MEDICAL LASER |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | FUTURE DEVICE AND TECHNOLOGY, INC 4322 WILSHIRE BLVD., SUITE 303 Los Angeles, CA 90010 |
| Contact | Soungdon Chung |
| Correspondent | Soungdon Chung FUTURE DEVICE AND TECHNOLOGY, INC 4322 WILSHIRE BLVD., SUITE 303 Los Angeles, CA 90010 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2014-05-12 |
| Summary: | summary |