510(k) Report

FDA applicant

Hair International Systems USA, Inc.

Newport Beach, CA1 decision2006–20060 recalls

FDA records 1 decision for Hair International Systems USA, Inc. (Newport Beach, CA) in 2006: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Hair International Systems USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hair International Systems USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hair International Systems USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hair International Systems USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc. · 2006

The one decision as Hair International Systems USA, Inc. →