The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Healite Ii System.
| Device ID | K113668 |
| 510k Number | K113668 |
| Device Name: | HEALITE II SYSTEM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | LUTRONIC CORPORATION 6 NESHAMINY INTERPLEX, SUITE 207 Trevose, PA 19053 |
| Contact | Jhung Won Vojir |
| Correspondent | Jhung Won Vojir LUTRONIC CORPORATION 6 NESHAMINY INTERPLEX, SUITE 207 Trevose, PA 19053 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-13 |
| Decision Date | 2012-06-19 |
| Summary: | summary |