The following data is part of a premarket notification filed by Lightmed Corp. with the FDA for Lightlas 810 Infrared Laser Photocoagulator.
| Device ID | K021538 |
| 510k Number | K021538 |
| Device Name: | LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR |
| Classification | Laser, Ophthalmic |
| Applicant | LIGHTMED CORP. NO.1-1, LANE1,PAO-AN ST. SEC.3 Shulin City, TW 238 |
| Contact | Irene Lin |
| Correspondent | Irene Lin 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 | 2002-05-10 |
| Decision Date | 2002-08-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712826770635 | K021538 | 000 |