The following data is part of a premarket notification filed by Lightmed Corp. with the FDA for Lightlas 577 Medical Optical Pumped Semiconductor Laser.
| Device ID | K091981 |
| 510k Number | K091981 |
| Device Name: | LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER |
| Classification | Laser, Ophthalmic |
| Applicant | LIGHTMED CORP. NO.1-1, LANE1,PAO-AN ST. SEC.3 SHULIN CITY Taipei, TW 238 |
| Contact | Anita Chen |
| Correspondent | Anita Chen LIGHTMED CORP. NO.1-1, LANE1,PAO-AN ST. SEC.3 SHULIN CITY Taipei, 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 | 2009-07-01 |
| Decision Date | 2009-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712826770642 | K091981 | 000 |