Understanding MimiSilk Iris's FDA 510(k) Clearance Status

Some customers who search for MimiSilk Iris's FDA 510(k) clearance number, K182498, may notice that the FDA database displays a company called Unimed rather than MimiSilk or Iris. This can understandably raise questions about whether the clearance number belongs to our product.

We want to clarify why this happens and show you how to independently verify the information through the FDA's official databases.

The difference comes down to a change in our manufacturer's company name. Although the original FDA clearance record still displays the manufacturer's former name, the current manufacturer and its connection to MimiSilk can be verified through the FDA's Establishment Registration & Device Listing database.

1. Why Does the FDA Database Show a Different Company Name?

MimiSilk Iris's FDA 510(k) clearance number is K182498. When you search for this number in the FDA's 510(k) Premarket Notification database, the record identifies "Unimed Laser Technology Co., Ltd." as the applicant.

Unimed is the former name of our manufacturer. They subsequently changed their company name to "Olemy Laser Technology Co., Ltd." As a result, the original 510(k) record continues to display the former company name rather than the current one, even though a request to update the name has been submitted to the FDA.

You can find Olemy Laser Technology Co., Ltd. identified as the manufacturer on the cover of Iris's product instruction manual.

2. How to Verify on the FDA Website

You can independently verify Olemy's current establishment registration and its association with MimiSilk through the FDA's Establishment Registration & Device Listing database.

Here's how:

Step 1. Visit the FDA's Establishment Registration & Device Listing database.

Go to the FDA's official search page.

Step 2. Search for Olemy.

Under the "Establishment or Trade Name" field, enter Olemy, then click Search.

Step 3. Select Olemy Laser Technology Ltd.

Find Olemy Laser Technology Ltd. in the search results and click its name to view the establishment details.

Step 4. Look for MimiSilk under Business Trade Name.

On the establishment details page, you'll find MimiSilk listed under the "Business Trade Name" field. (Also, YDUNVIE is our business trade name in the Chinese market.)

3. How to Verify Iris's FDA Device Listing

You can also check Olemy's device listing in the same FDA database.

Our manufacturer, Olemy, currently has only one device listed in the database, and its listing is associated with 510(k) number K182498. This is the same 510(k) clearance number that Iris has. Together with the manufacturer's current registration information, this provides another way to trace the connection between the FDA clearance number and Iris.

4. Bringing It All Together

To summarize, the different names appearing in the FDA databases refer to different aspects of the same manufacturer and product:

Name	What It Refers To
Unimed	Our manufacturer's former company name, shown in the original 510(k) record
Olemy Laser Technology	The manufacturer's current company name
MimiSilk	The business trade name registered under Olemy
Iris	MimiSilk's device associated with 510(k) clearance K182498

We understand that seeing different names when searching for Iris's FDA clearance information can be confusing. We hope this explanation and verification guide makes it easier to understand the records and helps you independently check the information.

MimiSilk Iris's FDA 510(k) clearance number is K182498. You can use the official FDA links above to review the clearance record and the manufacturer's current registration and device listing information.