The following data is part of a premarket notification filed by Lameditech Co., Ltd. with the FDA for Lmt-3000.
| Device ID | K172818 |
| 510k Number | K172818 |
| Device Name: | LMT-3000 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Lameditech Co., Ltd. #1002, ACE High End Tower 6th 234, Beotkkot-ro, Geumcheon-gu, KR |
| Contact | Jong Seuk Choi |
| Correspondent | Carrie Hetrick Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2018-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800031600062 | K172818 | 000 |
| 08800031600086 | K172818 | 000 |