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Sebacia Microparticles SEB-250-3P-US

by Sebacia, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20850002391019 UDI-DI Date19 Jun 2020ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sebacia Microparticles
Generic Name
Photothermal therapy gel
Model / Ref / Catalog
SEB-250-3P-US
Primary DI / UDI-DI
20850002391019
510(k) Number
FDA Product Code
QCY
GMDN Term
Photothermal therapy gel
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 3 Milliliter

Related devices

Category: Photothermal therapy gel

Cleared under the same submission (K181518)

Other devices from Sebacia, Inc.

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No