Threads
NovaThreads PDO threads
Ectoderma dba CosmoFrance (per FDA MAUDE report)
What it is
- Maker
- Ectoderma dba CosmoFrance (per FDA MAUDE report)
- Category
- Threads
- Also called
- NovaThreads, Nova Threads, PDO threads
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. An FDA MAUDE report (report date 2024-06-10) for brand NOVATHREADS, common name PDO suture, manufacturer Ectoderma dba CosmoFrance (Miami, FL), product code NEW, cites 510(k) K191361. FDA's 510(k) database lists K191361 as 'DemeDIOX Barbed Absorbable Surgical Suture' from Demetech Corporation (cleared 2019-11-07, 21 CFR 878.4840). No opened FDA page confirms NovaThreads is marketed under that clearance, so no pathway is asserted. The MAUDE report describes a thread extruding from the skin; individual MAUDE reports are unverified and do not establish cause.
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
- FDA MAUDE adverse event report naming brand NOVATHREADS (PDO suture) (opens in a new tab)FDA database
- FDA 510(k) database: K191361 (DemeDIOX Barbed Absorbable Surgical Suture) (opens in a new tab)FDA database
Checked Sep 14, 2026 · Partly confirmed.
Treatments that use it
No treatment guide lists this product yet.
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