Shenzhen Ionka Medical Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 1 device type, 1 product catalogued, 2 clearances.
Shenzhen Ionka Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Light Based Over-The-Counter Hair Removal. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
1device type
1product
2510(k) clearances
Registration
| Registered name | Shenzhen IONKA Medical Technology Co., Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3026132991 |
| FEI number | 3026132991 |
| DUNS | 707411576 |
| Establishment type | Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Room 601, No. 3, Jiazitang Second Industrial Zone, Jiazitang Community, Fenghuang Street, Guangming District |
| Postal code | 518132 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Light Based Over-The-Counter Hair Removal | Class 2 | Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 | 2023 | 69 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Hand-held IPL device (IPL Home Use Hair Removal Device) | OHT | 4 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K230739 | 2023-05-26 | OHT | Traditional | This company |
| K221214 | 2022-09-21 | ONF | Traditional | This company |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.