The following data is part of a premarket notification filed by Advanced Biomedical Instruments with the FDA for Biolas Yag 100 Cilas, Ercelas Yag 100.
| Device ID | K843156 |
| 510k Number | K843156 |
| Device Name: | BIOLAS YAG 100 CILAS, ERCELAS YAG 100 |
| Classification | Laser For Gastro-urology Use |
| Applicant | ADVANCED BIOMEDICAL INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-10 |
| Decision Date | 1984-10-01 |