The following data is part of a premarket notification filed by Finemec Co., Ltd. with the FDA for Nobleen Long Pulsed Alexandrite & Nd: Yag Laser System.
Device ID | K182663 |
510k Number | K182663 |
Device Name: | Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System |
Classification | Powered Laser Surgical Instrument |
Applicant | FineMEC Co., Ltd. #604-1, 217, Heojun-ro, Gangseo-gu Seoul, KR 07531 |
Contact | William H. Mcgrail |
Correspondent | William H. Mcgrail McGrail Consulting, LLC 62 Dale Road Meredith, NH 03253 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-25 |
Decision Date | 2018-11-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08809590140217 | K182663 | 000 |