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BBLs

by Sciton, Inc.

BBLs (1500-066-00) is a multi-modality skin surface treatment system (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Sciton, Inc., listed in FDA GUDID since 12 Feb 2018 (UDI-DI 00863249000312), registry data as of 21 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00863249000312 UDI-DI Date12 Feb 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Multi-modality skin surface treatment system
Model / Ref / Catalog
BBLs, 1500-066-00
Primary DI / UDI-DI
00863249000312
FDA product code
GEX
GMDN term
Multi-modality skin surface treatment system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Multi-modality skin surface treatment system.

Other devices from Sciton, Inc.

See all devices from Sciton, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)