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 |