The following data is part of a premarket notification filed by Coreleader Biotech Co., Ltd. with the FDA for Coreleader Scar-dimmer.
| Device ID | K111733 |
| 510k Number | K111733 |
| Device Name: | CORELEADER SCAR-DIMMER |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | CORELEADER BIOTECH CO., LTD. 19F NO. 100, SEC 1 SINTAI 5TH RD, SIJHIH DIST New Taipei, Taiwan, TW 22102 |
| Contact | Ian Li |
| Correspondent | Ian Li CORELEADER BIOTECH CO., LTD. 19F NO. 100, SEC 1 SINTAI 5TH RD, SIJHIH DIST New Taipei, Taiwan, TW 22102 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-21 |
| Decision Date | 2011-09-22 |
| Summary: | summary |