The following data is part of a premarket notification filed by Won Technology Co., Ltd. with the FDA for Pastelle Q-switched Nd: Yag Laser.
| Device ID | K123293 |
| 510k Number | K123293 |
| Device Name: | PASTELLE Q-SWITCHED ND: YAG LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | WON TECHNOLOGY CO., LTD. 24125 85TH AVE. SE Woodinville, WA 98072 |
| Contact | Roberta Hines |
| Correspondent | Roberta Hines WON TECHNOLOGY CO., LTD. 24125 85TH AVE. SE Woodinville, WA 98072 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-22 |
| Decision Date | 2013-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800022300803 | K123293 | 000 |