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Hand-held IPL device (IPL Home Use Hair Removal Device)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Hand-held IPL device (IPL Home Use Hair Removal Device) FDA UDI
- Generic Name
- Home-use intense pulsed light hair removal unit FDA UDI
- Device Name
- IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. FDA UDI
- Model / Reference
- FZ-608G FDA UDI
- Description
- IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973071106183 FDA UDI
- 510(k) Number
- K230739 FDA UDI
- FDA Product Code
- OHT FDA UDI
- GMDN Term
- Home-use intense pulsed light hair removal unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Home-use intense pulsed light hair removal unit
Hand-held IPL device (IPL Home Use Hair Removal Device) by Shenzhen Ionka Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Home-use intense pulsed light hair removal unit.
- IPL Home Use Hair Removal Device — Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. · Class II
- Braun Silk.expert Pro 3 — PROCTER & GAMBLE MANUFACTURING COMPANY, THE · Class II
- Braun Silk.expert Pro 3 — PROCTER & GAMBLE MANUFACTURING COMPANY, THE · Class II
- Mlay — Shenzhen Mlay Intelligent Technology Co., Ltd. · Class II
- Ulike — Shenzhen Ulike Smart Electronics Co., Ltd. · Class II
- Mlay — Shenzhen Mlay Intelligent Technology Co., Ltd. · Class II
- Ulike — Shenzhen Ulike Smart Electronics Co., Ltd. · Class II
- Braun Silk.expert Pro 5 — PROCTER & GAMBLE MANUFACTURING COMPANY, THE · Class II
Cleared under the same submission
K230739 also covers:
- Hand-held IPL device (IPL Home Use Hair Removal Device) — Shenzhen Ionka Medical Technology Co., Ltd.
- Hand-held IPL device (IPL Home Use Hair Removal Device) — Shenzhen Ionka Medical Technology Co., Ltd.
- Hand-held IPL device (IPL Home Use Hair Removal Device) — Shenzhen Ionka Medical Technology Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Ionka Medical Technology Co., Ltd.
Sources (1)
- FDA UDI c1f1e1d8-6923-4e79-b3ac-2425b836c28b 34 fields · synced May 30, 2026