Model note · Skin Resurfacing Laser
Candela GentleMax Pro Laser System
The GentleMax Pro is a dual wavelength dermatology laser that houses a flashlamp pumped 755 nm alexandrite head and a 1064 nm Nd:YAG head in one cart. Both beams are combined onto the same path and leave through one fibre and handpiece. It is best known for hair reduction but is also cleared for vascular and pigmented lesions, wrinkles and onychomycosis, with cryogen spray cooling (the Dynamic Cooling Device) protecting the epidermis.
The model
Maker, model and type.
- Maker
- Candela Corporation
- Model
- GentleMax Pro Laser System
- Device type
- Skin Resurfacing Laser
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Laser sources | Flashlamp excited solid state alexandrite (755 nm) and Nd:YAG (1064 nm) | Source |
| Pulse duration and rate | 0.25 to 100 ms; up to 10 Hz | Source |
| Maximum fluence and delivered energy | 53 J/cm2 alexandrite, 80 J/cm2 Nd:YAG (510(k)); brochure gives 53 J and 80 J maximum delivered energy | Source |
| Spot sizes | Standard 6 to 18 mm; specialty 1.5, 3, 5 and 3 x 10 mm; large 20, 22 and 24 mm | Source |
| DCD cooling settings | HFC 134a cryogen; spray 20 to 100 ms, delay 10 to 100 ms, post spray 10 to 50 ms; air cooling handpiece optional | Source |
| Beam delivery and triggering | Lens coupled, user replaceable optical fibre to handpiece with distance gauge; finger switch or footswitch | Source |
| Electrical | 200 to 240 VAC, 50/60 Hz, 30 A, 4600 VA, single phase | Source |
| Size and weight | 107 x 46 x 69 cm (42 x 18 x 27 in); 118 kg (260 lb) | Source |
| FDA clearance | K140122 (GentleMAX Family, GentleMax Pro), product code GEX, Class II, 21 CFR 878.4810, cleared 9 May 2014; tested to IEC 60601-1 3rd ed, 60601-1-2 and 60601-2-22 | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- Candela lists burns, blistering, crusting, pigment change and rare scarring as possible responses, so settings and cooling must suit the skin type. Source
- MAUDE problem counts for the brand are led by use related codes (incorrect procedure, wrong settings), a reminder that operator training matters; these are trends, not rates. Source
- It was tested to IEC 60601-2-22, the particular standard for surgical and therapeutic lasers, so treatment room controls and eyewear must follow local laser safety rules. Source
Sources
Where this note comes from.
- FDA 510(k) K140122 summary, GentleMAX Family of Laser Systems (GentleMax Pro)
- Candela GentleMax Pro brochure PB76155EN-CH Rev A (APAC, 2019)
- openFDA recall search, Candela
- openFDA MAUDE problem counts, GentleMax brand
Not covered: A copy of the operator's manual exists on a university server but could not be reached, so no error messages, calibration steps or part numbers are included. No FDA recall names the GentleMax Pro. Candela's 2019 cryogen canister recall (Z-0206-2020 and related) was left out because FDA states it affected only legacy devices with screw in DCD modules, and the GentleLase Pro and Vbeam recalls are different products. The manual's own hazard zone and eyewear data were not available.
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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