The following data is part of a premarket notification filed by Finemec Co.,ltd. with the FDA for Noblex Long Pulse Alexandrite Laser.
| Device ID | K143666 |
| 510k Number | K143666 |
| Device Name: | Noblex Long Pulse Alexandrite Laser |
| Classification | Powered Laser Surgical Instrument |
| Applicant | FINEMEC CO.,LTD. #230,7, GALHYEON-RO 11GIL, EUNPYEONG-GU Seoul, KR 122-902 |
| Contact | Ghun Hee Lee |
| Correspondent | Shin Kuk Yoo LSK BIOPARTNERS, INC. 8 EAST BROADWAY, STE 611 Salt Lake City, UT 84111 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-23 |
| Decision Date | 2015-04-23 |
| Summary: | summary |