Lasers
Halo hybrid fractional laser by Sciton
Sciton, Inc.
What it is
- Maker
- Sciton, Inc.
- Category
- Lasers
- Also called
- Halo, Sciton Halo, Profile Halo, hybrid fractional laser
FDA status
No FDA pathway is on file for this entry. That is not a clearance, and it is not a finding that FDA has no record.
UNVERIFIED. No FDA 510(k) record naming 'Halo' was found among Sciton's openFDA 510(k) records (which list Profile and JOULE platform systems, e.g., K173285 Joule 2940 nm ProFractional, K182173 Joule 1927 nm, K213761 Joule diVa). Halo may be cleared as a module under a JOULE system clearance, but no opened FDA page confirmed this, so no pathway, number or indication is recorded.
How it’s sold
How it’s sold isn’t recorded for this entry.
What the label warns about
No label warning is recorded here. That isn’t the same as the label having none — the research notes and sources say what was opened.
Checking it’s the real thing
No FDA authenticity notice is recorded for this product.
Ask in the room
“What’s the brand name printed on the box, vial or device panel — and may I see it?”
Recalls and enforcement
FDA recall and enforcement records filed under this product’s FDA number, read live from openFDA. A recall usually covers particular models or lots, not every unit ever made.
Searching FDA recall and enforcement records by this product’s FDA number…
Check it yourself
Device proof ladder: The room sells a laser, RF, microneedling, body-contouring, light, or other hardware result. Work down in order — each step needs the one before it.
- Read the panelGet the exact manufacturer and model from the device itself.
- Find the authorizationSearch 510(k) and De Novo by model/manufacturer, not treatment nickname.510(k) Premarket Notification database (opens in a new tab) · U.S. Food & Drug Administration
- Match identityUse AccessGUDID when a UDI or device identifier is available.AccessGUDID (opens in a new tab) · FDA / National Library of Medicine
- Read maker instructionsCompare the proposed use with current manufacturer labeling/IFU for that exact model.
- Check post-market recordSearch recalls/corrections after the model is known.Medical Device Recalls (opens in a new tab) · U.S. Food & Drug Administration
- Verify the operatorThen check the person's applicable state credential and device-specific training.
Worth knowing
What an FDA record can and can’t tell you
FDA records show what was authorized, for what, and when.
They can’t show that the product in the room is authentic, in date, stored properly, or being used for its authorized purpose. Those are questions for the room.
Sources
No sources are recorded for this entry.
Checked Sep 14, 2026 · Partly confirmed.
Treatments that use it
Product identity
Told a name? Shown a box?
Type what was said or printed, see whether it matches a registry entry, and note what you saw in your booking file.
Check a name