Equipment profile · Candela
Candela PicoWay: Price, Specs, FDA Clearance and Alternatives
PicoWay is Candela’s picosecond laser for practices offering tattoo removal and pigment treatments, with Resolve fractional handpieces for acne scars and wrinkles. It uses 532, 730, 785 and 1064 nm wavelengths, and each carries its own FDA-cleared skin-type range.
The short answer
PicoWay is FDA cleared for tattoo removal by ink color and wavelength, benign pigmented lesions and, with Resolve handpieces, acne scars and wrinkles. Its 2022 clearance added melasma, café-au-lait macules, lentigines and nevus of Ota. Candela doesn’t publish prices, so compare quotes on the same handpiece configuration.
Who should buy a PicoWay?
Shortlist it if
- Tattoo removal is a real service line for you, including colored inks.
- You also want pigment and skin-quality treatments from the same laser.
- Your patients include darker skin types; the 1064 nm handpiece is cleared for tattoos on every skin type.
Compare another option if
- You want 755 nm picosecond treatments with the Focus lens: compare the PicoSure Pro.
- You want pigment and redness treatments without tattoo removal: compare Candela’s Nordlys.
Our take: which PicoWay configuration do you need?
Buy the handpieces your tattoo and pigment menu will use. Most tattoo work is dark ink on 1064 nm, which is cleared for all skin types. The 532, 730 and 785 nm handpieces add colored inks, each with a narrower skin-type range.
Add Resolve if you’ll market acne scar and wrinkle treatments, and get its price separately. Then confirm eyewear for every wavelength, service on the laser and training for each handpiece.
Document-based buying analysis. Not a NuWays MD hands-on test of this device.
PicoWay specifications at a glance
Before you compare
| Specification | PicoWay | What it means for your practice |
|---|---|---|
| Handpieces | Zoom 532/1064 nm (2 to 10 mm); 730 nm and 785 nm (2, 3 and 4 mm); Resolve and Resolve Fusion fractional handpieces | Each handpiece is a purchase decision; tattoo colors and indications depend on what you buy. |
| Tattoo colors | 1064 nm: black, brown, green, blue and purple (all skin types); 532 nm: red, yellow and orange (I to III); 730 and 785 nm: green and blue (II to IV) | The color handpieces matter if you market multicolor removal; each has a narrower skin-type range. |
| Skin quality | Resolve 1064 nm: acne scars (II to V) and melasma (I to IV); Resolve handpieces: wrinkles (I to IV) | Resolve takes the system beyond tattoos. Price it as its own line item. |
| Pigment | Benign pigmented lesions (I to IV), with 2022 indications for melasma, café-au-lait macules, lentigines and nevus of Ota | |
| Configurations | Candela lists five handpiece configurations | Compare quotes on the same configuration. |
Sources: Candela · FDA 510(k) K220853.
See it next to the alternativesSpecs, cleared uses and ownership questions in one table.
What is the PicoWay FDA cleared for?
Each 510(k) number links to its record in the FDA database. The summary PDFs are listed under Sources.
510(k) K220853 (PicoWay Laser System), cleared October 13, 2022. Product code GEX; Class II medical device. Added melasma, café-au-lait macule, lentigine and nevus of Ota indications to the 2019 clearance.
| Wavelength | Cleared uses (summarized) |
|---|---|
| 1064 nm | Tattoos (black, brown, green, blue, purple) on all skin types; melasma (I to IV); nevus of Ota (III to IV). |
| 532 nm | Tattoos (red, yellow, orange) on skin types I to III; melasma, café-au-lait macules and lentigines (I to IV). |
| 730 and 785 nm | Green and blue tattoos on skin types II to IV; lentigines at 730 nm. |
| Resolve | Acne scars (II to V) and melasma (I to IV) at 1064 nm; wrinkles (I to IV). |
Source: FDA 510(k) K220853.
510(k) K191685 (PicoWay Laser System), cleared September 16, 2019. Product code GEX; Class II medical device. The prior clearance the 2022 update built on.
Earlier clearances: K150326 (2015), K153527 and K160607 (2016), K162454 and K170597 (2017).
Source: FDA 510(k) K191685.
Clearance describes what a device may be marketed for; it does not predict results for a given patient.
PicoWay clinical studies
Published studies we found on this system, its earlier models and related technology, each labeled by what it tested. Most are small, and some have manufacturer-affiliated authors, so use them to frame questions for the demo rather than as proof of results.
What we found: 2 on this system.
- This systemA 1064-nm Neodymium-doped Yttrium Aluminum Garnet Picosecond Laser for the Treatment of Hyperpigmented ScarsFractional 1064 nm PicoWay treatment of the pigmented part of scars.
- This systemThe efficacy of 1064-nm Nd:YAG picosecond laser for Becker’s nevus: a retrospective analysis of 49 casesPicoWay 1064 nm treatment of Becker’s nevus, scored by two independent dermatologists.
Links open the PubMed record.
How much does a PicoWay cost?
| Price evidence | What we found |
|---|---|
| New system (manufacturer quote) | Candela does not publish prices, and we found no reliable public price for a new PicoWay. Get a quote that lists each handpiece. |
| Used (asking prices) | Not reviewed for this profile. On a used unit, confirm the handpieces, service history and Candela transfer terms. |
| Documented sale prices | None found. |
What ownership adds after purchase
| Cost area | What to confirm |
|---|---|
| Handpieces | Each wavelength and Resolve handpiece is priced separately; list what arrives and what later additions cost. |
| Eyewear | Each wavelength needs rated eyewear for staff and patients. Confirm what is included. |
| Service | Ask what the plan covers after the warranty, including the laser. |
| Training | Tattoo and pigment protocols differ; confirm training for each handpiece. |
PicoWay alternatives to compare
| Device | Technology | Why compare it |
|---|---|---|
| Cynosure PicoSure Pro | 755 nm picosecond laser | Cynosure’s 755 nm picosecond laser with the Focus lens and optional 532 and 1064 nm add-ons. |
| Candela Nordlys | SWT pulsed light and laser platform | Candela’s IPL and fractional platform for pigment and redness without tattoo removal. |
Different technologies are not interchangeable. Compare configurations, cleared uses and ownership costs before you book demos.
Questions to ask before you sign
- Which handpieces are included: Zoom 532/1064, 730, 785, Resolve or Resolve Fusion?
- Which tattoo colors and pigment indications does that configuration cover, by skin type?
- What does each handpiece cost if added later?
- Which eyewear is included for each wavelength?
- What does the warranty cover, and what does service cost from year two?
- How many training days are included, and what is the total with tax, freight, installation and financing?
Plan the purchase
Plan your PicoWay purchase.
- Compare it side by side with its closest alternatives.
- Check what each quote includes: configuration, supplies, service and financing.
- Model the monthly payment against realistic treatment volume in the ROI calculator.
Other tattoo removal lasers to research
All tattoo removal lasers →More Candela equipment →Full equipment catalog →
Sources
Show all 3 sources
- Candela: PicoWay (November 7, 2026). Checked November 7, 2026.
- FDA 510(k) K220853: PicoWay Laser System (October 13, 2022). Checked November 7, 2026.
- FDA 510(k) K191685: PicoWay Laser System (September 16, 2019). Checked November 7, 2026.