Hydradermabrasion devices
HydraFacial Syndeo
Not confirmed on an opened official page
What it is
- Maker
- Not confirmed on an opened official page
- Category
- Hydradermabrasion devices
- Also called
- HydraFacial, Hydra Facial, Syndeo, hydradermabrasion
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 510(k), De Novo or PMA record for 'HydraFacial' or 'Syndeo' was found: openFDA 510(k) device-name searches returned only an unrelated Baxter 'Syndeo PCA Syringe Pump' (K031566); FDA registration-and-listing proprietary-name queries for 'hydrafacial' and 'syndeo' returned no results; 510(k)s under the applicant name Edge Systems are for other products (sterile tubing, Del Sol light therapy). Whether the device is 510(k)-exempt or listed under another name was not verified, so no FDA status is stated. The manufacturer's Syndeo page URL tried returned 404.
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