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AcuPulse™ Upgrade Kit to AES-R 4 Modes Upgrade
FDA UDIClass II (US FDA UDI)
by Lumenis
Identity
- Trade Name
- AcuPulse™ Upgrade Kit to AES-R 4 Modes Upgrade FDA UDI
- Generic Name
- General/multiple surgical solid-state/carbon dioxide laser system FDA UDI
- Model / Reference
- AcuPulse™ Upgrade Kit to AES-R 4 Modes Upgrade FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109142944 FDA UDI
- 510(k) Number
- K100415 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical solid-state/carbon dioxide 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General/multiple surgical solid-state/carbon dioxide laser system
AcuPulse™ Upgrade Kit to AES-R 4 Modes Upgrade by Lumenis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General/multiple surgical solid-state/carbon dioxide laser system.
- MultiPulse PRO 60 — EL.EN. SPA · Class II
- IMLIGHT CO2 Laser — EL.EN. SPA · Class II
- DEKA SMARTXIDE² — EL.EN. SPA · Class II
- DEKA SmartXide² TRIO C60H — EL.EN. SPA · Class II
- MultiPulse PRO DUO — EL.EN. SPA · Class II
- Nd:Yag Laser Therapy Systems — BEIJING UNT Technology Co., Ltd. · Class II
- DEKA SmartXide² TRIO C80H — EL.EN. SPA · Class II
- DEKA SMARTXIDE² — EL.EN. SPA · Class II
Cleared under the same submission
K100415 also covers:
- AcuPulse™ DUO HW Upgrade kit AcuPulse™ 40WG to DUO — Lumenis
- AcuPulse™ DUO HW Upgrade kit AcuPulse™ to DUO — Lumenis
- AcuPulse™ Upgrade Kit 30 to 30ST — Lumenis
- AcuPulse™ Upgrade Kit 40 to 40ST — Lumenis
- AcuPulse™ Upgrade Kit 40AES-F to 40AES-A — Lumenis
- AcuPulse™ Upgrade Kit 40AES-R To 40AES-A — Lumenis
- AcuPulse™ Upgrade Kit to AES-A 4 Modes Upgrade — Lumenis
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
- Lumenis
Sources (1)
- FDA UDI 8eb61fcd-64a7-4702-81ea-91384d552a31 34 fields · synced May 30, 2026