Model note · Skin Resurfacing Laser
Lumenis UltraPulse CO2 surgical and aesthetic laser system
The UltraPulse is a 10,600 nm carbon dioxide laser used in dermatology and plastic surgery for full and fractional skin resurfacing and scar treatment, and in many surgical specialties for soft tissue cutting, vaporisation and coagulation. Its distinguishing feature is a high peak power, very short pulse mode that ablates deeply with less surrounding heat, delivered through an articulated arm to scanners such as DeepFX, ActiveFX and SCAAR FX.
The model
Maker, model and type.
- Maker
- Lumenis Be Ltd. (formerly Lumenis Ltd.; surgical UltraPulse models now also sold by Boston Scientific)
- Model
- UltraPulse CO2 surgical and aesthetic laser system
- Device type
- Skin Resurfacing Laser
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Wavelength | 10,600 nm | Source |
| Laser type | UltraPulse (pulsed) and continuous wave; RF modulated CO2 laser tube | Source |
| Power | 60 W to tissue; 240 W peak | Source |
| Spot size and scan | 0.12 mm to 2.0 mm TrueSpot; scan area up to 15 x 15 mm; fractional density 1 to 82 percent | Source |
| Aiming beam | 5 mW red diode laser, 635 nm, adjustable intensity | Source |
| Beam delivery | Articulated arm, 240 cm reach, 360 degree rotation | Source |
| Cooling | Self contained closed cycle | Source |
| Electrical | 100 to 240 V AC, 20 A maximum, 50/60 Hz | Source |
| Size and weight | 34 x 51 x 144 to 195 cm; 128 kg | Source |
| FDA clearance | 510(k) K203544 (special), decision 24 December 2020, product code GEX, class II; predicate K151331 | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- A misaligned arm can fire the beam away from where the aiming beam shows, risking unintended tissue injury. Source
- Faults that cannot be cleared can abort procedures with the patient sedated or anaesthetised, so a backup plan is needed. Source
- The system is a surgical laser tested to IEC 60825-1 and IEC 60601-2-22, so the laser safety controls the 510(k) lists (safety controls, emission indicator) must be verified as working. Source
Sources
Where this note comes from.
- Lumenis UltraPulse brochure PB-1124760 Rev G
- FDA 510(k) summary K203544, UltraPulse
- openFDA MAUDE problem counts, UltraPulse
- openFDA MAUDE narratives, UltraPulse failure to align
- openFDA recall search, UltraPulse (no results)
Not covered: No FDA recall names the UltraPulse, the operator and service manuals are not public, and MAUDE brand data mixes several UltraPulse generations (Encore, DUO, SurgiTouch), so failure patterns may not all apply to the current console; only one error message could be sourced, from a single MAUDE report.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Skin Resurfacing Laser
Other models of this device.
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