Identity
- Trade Name
- Medical San FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Device Name
- The Dermatological Diode Laser (Model: Hakon) is intended for the removal, permanent reduction of hair on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent hair reduction is defined as the stable, long-term reduction in the number of hairs growing back when measured at 6, 9, and 12 months after completion of a treatment regimen. FDA UDI
- Model / Reference
- Hakon FDA UDI
- Description
- The Dermatological Diode Laser (Model: Hakon) is intended for the removal, permanent reduction of hair on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent hair reduction is defined as the stable, long-term reduction in the number of hairs growing back when measured at 6, 9, and 12 months after completion of a treatment regimen. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07898672790311 FDA UDI
- 510(k) Number
- K231901 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological diode laser system 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
Yes
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Dermatological diode laser system
Medical San by Medical San Industria De Equipamentos Medicos Ltda — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological diode laser system.
- Emerge Handpiece — Cynosure, LLC · Class II
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- VIKINI Laser H/P — ILOODA.CO., LTD · Class II
- HAIR REMOVAL LASER — TRIA LASER INC · Class II
- HAIR REMOVAL LASER — TRIA LASER INC · Class II
- Diode Laser Therapy Machine — Beijing ADSS Development Co., Ltd. · Class II
- DioBreeze — FORMATK SYSTEMS LTD · Class II
- TwinScan 808/755 Laser System — GME German Medical Engineering GmbH · Class II
Cleared under the same submission
K231901 also covers:
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
- Medical San Industria De Equipamentos Medicos Ltda
Sources (1)
- FDA UDI ac65b4ac-a2af-41df-b1ff-71033cc38786 34 fields · synced Jun 1, 2026