Exact FDA event identifier

Event 96034

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: October 16, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: IDS LTD

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Smaxel Fractional CO2 Laser, a Class IV medical laser system.

Z-0804-2025

Recall number: Z-0804-2025
Initiated: October 16, 2024
Classification: Class II
Status: Ongoing
Recalling firm: IDS LTD
Quantity: 23

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.

Code information

unknown

Distribution pattern

Worldwide - US Nationwide Distribution