The following data is part of a premarket notification filed by Medical Lasers Manufacturer Inc. with the FDA for The Time Machine Series Lasers.
| Device ID | K152461 |
| 510k Number | K152461 |
| Device Name: | The Time Machine Series Lasers |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | MEDICAL LASERS MANUFACTURER INC. 4400 ROUTE 9 SOUTH, SUITE 1000 Freehold, NJ 07728 |
| Contact | Bruce Schoengood |
| Correspondent | Jigar Shah MDI CONSULTANTS, INC. 55 NORTHERN BOULEVARD SUITE 200 Great Neck, NY 11021 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-28 |
| Decision Date | 2016-07-08 |
| Summary: | summary |