The following data is part of a premarket notification filed by Ya-man Ltd with the FDA for L-ser Ko Lamp.
| Device ID | K112016 |
| 510k Number | K112016 |
| Device Name: | L-SER KO LAMP |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | YA-MAN LTD 9210 FOREST HILL AVE STE B-3 Richmond, VA 23235 |
| Contact | Nelson Marquina |
| Correspondent | Nelson Marquina YA-MAN LTD 9210 FOREST HILL AVE STE B-3 Richmond, VA 23235 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-14 |
| Decision Date | 2012-02-10 |
| Summary: | summary |