The following data is part of a premarket notification filed by Bluecore Co.,ltd. with the FDA for Bm.iris.
| Device ID | K171648 |
| 510k Number | K171648 |
| Device Name: | BM.IRIS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Bluecore Co.,Ltd. Acehigh 21, 48 Centum-Jungang Ro 128 Haeundae-gu, KR |
| Contact | Bill Choi |
| Correspondent | Young Chi Bio-Med USA Inc 111 Ellison Street Paterson, NJ 07446 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-05 |
| Decision Date | 2017-09-08 |
| Summary: | summary |