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Isolaz IS2-TIP-AC-L-4

by Solta Medical, Inc.

Isolaz IS2-TIP-AC-L-4 is a Class II device made by Solta Medical, Inc., listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00816995020332), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816995020332 UDI-DI Date23 Sep 2016ListedStatusListed 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  • Withdrawn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

Trade name
Isolaz
Generic name
Multi-modality skin surface treatment system
Model / Ref / Catalog
IS2-TIP-AC-L-4
Primary DI / UDI-DI
00816995020332
FDA product code
ONF
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 Solta Medical, Inc.

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)