The following data is part of a premarket notification filed by Lightmed Corp. with the FDA for Lightlas Multi-wavelength Medical Laser System.
| Device ID | K103547 |
| 510k Number | K103547 |
| Device Name: | LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM |
| Classification | Laser, Ophthalmic |
| Applicant | LIGHTMED CORP. NO.1-1, LANE1,PAO-AN ST. SEC.3 Shulin City, TW 238 |
| Contact | Jocelyn Liu |
| Correspondent | Jocelyn Liu LIGHTMED CORP. NO.1-1, LANE1,PAO-AN ST. SEC.3 Shulin City, TW 238 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-02 |
| Decision Date | 2011-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712826770659 | K103547 | 000 |