Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
FDA 510(k) clearance K230739 · decided 2023-05-26
Clearance details
- K-number
- K230739
- Device name
- Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
- Applicant
- Shenzhen Ionka Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-03-17
- Decision date
- 2023-05-26
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- OHT
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.