Identity
- Trade Name
- Diode 810nm Compact For Alma Beauty Remove FDA UDI
- Generic Name
- Ultrasonic hyperthermia system FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- AASP01031501 FDA UDI
- Primary DI / UDI-DI
- 17290110120600 FDA UDI
- 510(k) Number
- K140009 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Ultrasonic hyperthermia 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
No
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
Category: Ultrasonic hyperthermia system
Diode 810nm Compact For Alma Beauty Remove by Alma Lasers Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasonic hyperthermia system.
- 7290019402558 — Insightec · Class III
- Sonasource — Focus Surgery, Inc. · Class II
- Sonablate — Focus Surgery, Inc. · Class II
- Sonablate Insertion Pack — Focus Surgery, Inc. · Class II
- Sonachill — Focus Surgery, Inc. · Class II
- Exablate Neuro Treatment Accessories Kit — Insightec · Class III
- Quantel Er 7X7 Pixel — ALMA LASERS LTD. · Class II
- Accent Elite Unilarge HP — ALMA LASERS LTD. · Class II
Cleared under the same submission
K140009 also covers:
- Diode 810nm Compact For Soprano Ice — ALMA LASERS LTD.
- Diode 810nm Compact For Soprano Ice & Xli (New) — ALMA LASERS LTD.
- Diode 810nm Compact HP For Soprano Ice & Xli & Facial tip — ALMA LASERS LTD.
- Diode 810nm Compact Handpiece for Soprano XL — ALMA LASERS LTD.
- Diode 810nm Compact Handpiece for Soprano XL (New) — ALMA LASERS LTD.
- Diode 810nm Handpiece for Soprano — ALMA LASERS LTD.
- Diode 810nm Handpiece for old Soprano XLi — ALMA LASERS LTD.
- Diode 810nm Speed HP For Soprano Ice & Xli — ALMA LASERS LTD.
- Diode 810nm Speed HP For Soprano Pontiac White — ALMA LASERS LTD.
- Diode 810nm Speed HP For old Soprano Ice — ALMA LASERS LTD.
- Diode 810nm Speed Handpiece for Soprano XL — ALMA LASERS LTD.
- Diode Alex 755nm 1.5cm HP Soprano Ice & Xli — ALMA LASERS 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alma Lasers Ltd.
Sources (1)
- FDA UDI 441467d6-8827-4c60-9a88-4c2358fb4759 34 fields · synced May 30, 2026