The following data is part of a premarket notification filed by Lightmed Corp. with the FDA for Lightmed Truscan 577.
| Device ID | K142172 |
| 510k Number | K142172 |
| Device Name: | LIGHTMED TRUSCAN 577 |
| Classification | Laser, Ophthalmic |
| Applicant | LIGHTMED CORP. NO.1-1, LANE1,PAO-AN ST. SEC.3 SHULIN DIST New Taipei City, TW 23861 |
| Contact | Angel Hsieh |
| Correspondent | Angel Hsieh LIGHTMED CORP. NO.1-1, LANE1,PAO-AN ST. SEC.3 SHULIN DIST New Taipei City, TW 23861 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-07 |
| Decision Date | 2015-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712826770680 | K142172 | 000 |