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.
| Item | Value | Source |
|---|---|---|
| Wavelengths and sources | 755 nm alexandrite; optional 1064 nm Nd:YVO4 and 532 nm frequency doubled Nd:YVO4 delivery systems | Source |
| Pulse width | 450 to 900 ps | Source |
| Maximum average fluence | 755 nm 6.37 J/cm2; 1064 nm 3.6 J/cm2; 532 nm 1.5 J/cm2 | Source |
| Repetition rate | 755 nm single shot, 1, 2.5, 5 or 10 Hz; 1064 and 532 nm 1, 2.5, 5 or 10 Hz | Source |
| Spot sizes | 755 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 mm | Source |
| Electrical | 200 to 240 V, 4.5 kVA, 50/60 Hz, single phase | Source |
| Size and weight | 109 x 56 x 107 cm (158 cm high with arm extended); 171 kg (375 lb) | Source |
| Activation and contact material | Footswitch activation; patient contacting parts 316 stainless steel; prescription use | Source |
| FDA clearance | K210226 (adds nevus of Ota, Hori macules and melasma), predicate K173199; original clearance K121346; product code GEX, Class II, 21 CFR 878.4810 | Source |
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.
- Cynosure PicoSure product page
- FDA 510(k) K210226 summary, PicoSure Workstation
- openFDA recall search, Cynosure
- openFDA MAUDE problem counts, PicoSure brand
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.
Skin Resurfacing Laser
Other models of this device.
Next