The following data is part of a premarket notification filed by Cosmo Far East Technology Limited with the FDA for Diode Laser Cap.
Device ID | K173678 |
510k Number | K173678 |
Device Name: | Diode Laser Cap |
Classification | Laser, Comb, Hair |
Applicant | Cosmo Far East Technology Limited Room 1504, Building 1, XingJiJia Yuan, Bao'an Avenue Songgang, Bao'an District Shenzhen, CN 518000 |
Contact | Bob An |
Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road Shenzhen, CN 518000 |
Product Code | OAP |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-30 |
Decision Date | 2018-02-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06973416570303 | K173678 | 000 |
06973416570204 | K173678 | 000 |
06973416570105 | K173678 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() DIODE LASER CAP 90079884 not registered Live/Pending |
Cosmo Far East Technology Limited 2020-07-29 |