The following data is part of a premarket notification filed by Norseld Pty., Ltd. with the FDA for Dual Yellow Laser, Model D10b.
| Device ID | K023899 |
| 510k Number | K023899 |
| Device Name: | DUAL YELLOW LASER, MODEL D10B |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NORSELD PTY., LTD. 342 SUNSET BAY RD. Hot Springs, AR 71913 |
| Contact | Roger W Barnes |
| Correspondent | Roger W Barnes NORSELD PTY., LTD. 342 SUNSET BAY RD. Hot Springs, AR 71913 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-22 |
| Decision Date | 2003-02-20 |
| Summary: | summary |