FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
K Number: K151331
·
Decision Jun 30, 2015
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
28
Review Days
42
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Basic Information
- Device Name
- The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
- K Number
- K151331
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lumenis, Ltd.
- Date Received
- May 19, 2015
- Decision Date
- June 30, 2015
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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| K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Oct 22, 2020 | Substantially Equivalent |
| K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Jul 16, 2020 | Substantially Equivalent |
| K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | Jan 16, 2020 | Substantially Equivalent |
| K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO | Apr 3, 2018 | Substantially Equivalent |
| K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity | Sep 18, 2017 | Substantially Equivalent |
| K170060 | M22 and ResurFx Systems | Aug 9, 2017 | Substantially Equivalent |
| K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories | May 22, 2017 | Substantially Equivalent |