The following data is part of a premarket notification filed by Vydence Medical Industria E Comercio Ltda with the FDA for Handpico.
| Device ID | K220041 |
| 510k Number | K220041 |
| Device Name: | HandPICO |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Vydence Medical Industria E Comercio Ltda Rua Aldo Germano Klein, 359 CEP: 13.573-470 - Caixa Postal 772 Ceat - Sao Carlos/sp Sao Paulo, BR 13.573-470 |
| Contact | Kathy Maynor |
| Correspondent | Kathy Maynor Kathy Maynor 26 Rebecca Ct Homosassa, FL 34446 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-05 |
| Decision Date | 2022-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07898961835266 | K220041 | 000 |
| 07898961835426 | K220041 | 000 |