The following data is part of a premarket notification filed by Lhasa Oms, Inc. with the FDA for Ir Pro 250.
| Device ID | K061080 |
| 510k Number | K061080 |
| Device Name: | IR PRO 250 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | LHASA OMS, INC. 230 LIBBEY PKWY. Weymouth, MA 02189 |
| Contact | Mark W Sheehan |
| Correspondent | Mark W Sheehan LHASA OMS, INC. 230 LIBBEY PKWY. Weymouth, MA 02189 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-18 |
| Decision Date | 2006-06-14 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IR PRO 250 78954998 3344276 Dead/Cancelled |
Lhasa OMS, Inc. 2006-08-18 |