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Model note · Skin Resurfacing Laser

Cynosure PicoSure Workstation

PicoSure is a picosecond pulse alexandrite laser workstation for tattoo removal and benign pigmented lesions, with optional 532 nm and 1064 nm delivery systems for other ink colours and darker skin. With the Focus lens array and the 2 mm and 6 mm handpieces it is also cleared for acne scars and wrinkles. Very short pulses aim to break pigment mainly by photomechanical effect with little heat spread.

The model

Maker, model and type.

Maker
Cynosure, LLC
Model
PicoSure Workstation
Device type
Skin Resurfacing Laser
Main document
Open the public document

Key specifications

What the public record says.

ItemValueSource
Wavelengths and sources755 nm alexandrite; optional 1064 nm Nd:YVO4 and 532 nm frequency doubled Nd:YVO4 delivery systemsSource
Pulse width450 to 900 psSource
Maximum average fluence755 nm 6.37 J/cm2; 1064 nm 3.6 J/cm2; 532 nm 1.5 J/cm2Source
Repetition rate755 nm single shot, 1, 2.5, 5 or 10 Hz; 1064 and 532 nm 1, 2.5, 5 or 10 HzSource
Spot sizes755 nm zoom 2 to 6 mm and fixed 6, 8, 10 mm; 1064 nm fixed 1.4 to 4.0 mm; 532 nm fixed 1.5 to 3.5 mmSource
Electrical200 to 240 V, 4.5 kVA, 50/60 Hz, single phaseSource
Size and weight109 x 56 x 107 cm (158 cm high with arm extended); 171 kg (375 lb)Source
Activation and contact materialFootswitch activation; patient contacting parts 316 stainless steel; prescription useSource
FDA clearanceK210226 (adds nevus of Ota, Hori macules and melasma), predicate K173199; original clearance K121346; product code GEX, Class II, 21 CFR 878.4810Source

Recalls

Recalls.

This note lists no recalls. Check the FDA recall database for the latest record.

Safety

Safety warnings from the record.

  • MAUDE for the brand includes a fire report and many adverse event codes; keep fire safety and laser room controls in place for every session. Source
  • Acne scar and wrinkle use is cleared only with the 2 mm and 6 mm handpieces and Focus array in skin types I to IV. Source
  • Cynosure says redness after Focus treatments usually settles within hours but can last up to a day, which patients should be told. Source

Sources

Where this note comes from.

Not covered: No public PicoSure operator or service manual was found, so there are no error messages, calibration steps, cooling or part details. No FDA recall names PicoSure; Cynosure's two recalls cover Elite MPX and RevLite accessories. A newer 510(k), K261570 (June 2026), exists but was not reviewed.

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.