The following data is part of a premarket notification filed by Advanced Technology Laser Co., Ltd. with the FDA for Q-switched Nd:yag Laser System, Model Globalcure-sc6.
Device ID | K102050 |
510k Number | K102050 |
Device Name: | Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 |
Classification | Powered Laser Surgical Instrument |
Applicant | ADVANCED TECHNOLOGY LASER CO., LTD. LN 999, ZHONGSHAN #2 RD (S) SUITE 5D, NO 19 Shanghai, CN 200030 |
Contact | Diana Hong |
Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2010-07-21 |
Decision Date | 2010-07-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06970507240206 | K102050 | 000 |