The following data is part of a premarket notification filed by Light-med(usa), Inc. with the FDA for Lightlas Pattern Scanning System - Truscan Pro.
| Device ID | K190448 |
| 510k Number | K190448 |
| Device Name: | LightLas Pattern Scanning System - TruScan Pro |
| Classification | Laser, Ophthalmic |
| Applicant | Light-Med(USA), INC. 1130 Calle Cordillera San Clemente, CA 92673 |
| Contact | Hedy Chiang |
| Correspondent | Hedy Chiang Light-Med(USA), INC. 1130 Calle Cordillera San Clemente, CA 92673 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-25 |
| Decision Date | 2019-05-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712826771007 | K190448 | 000 |
| 04712826770789 | K190448 | 000 |
| 04712826770796 | K190448 | 000 |
| 04712826770802 | K190448 | 000 |
| 04712826770819 | K190448 | 000 |
| 04712826770826 | K190448 | 000 |
| 04712826770833 | K190448 | 000 |
| 04712826770840 | K190448 | 000 |
| 04712826770857 | K190448 | 000 |
| 04712826770864 | K190448 | 000 |
| 04712826770871 | K190448 | 000 |
| 04712826770888 | K190448 | 000 |
| 04712826770970 | K190448 | 000 |
| 04712826770987 | K190448 | 000 |
| 04712826770994 | K190448 | 000 |
| 04712826770772 | K190448 | 000 |