The following data is part of a premarket notification filed by Shang Fa Biotechnology Co. with the FDA for Laser Hair Growth Cap.
| Device ID | K192627 |
| 510k Number | K192627 |
| Device Name: | Laser Hair Growth Cap |
| Classification | Laser, Comb, Hair |
| Applicant | Shang Fa Biotechnology Co. B1F., No. 6, Ln. 1, Qingli St., Tucheng Dist., New Taipei City, TW 23677 |
| Contact | Chung Ju Zhi |
| Correspondent | Chung Ju Zhi Shang Fa Biotechnology Co. B1F., No. 6, Ln. 1, Qingli St., Tucheng Dist., New Taipei City, TW 23677 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-23 |
| Decision Date | 2019-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719892822800 | K192627 | 000 |
| 04719892822725 | K192627 | 000 |
| 04719892821476 | K192627 | 000 |
| 04719892820806 | K192627 | 000 |