510(k) Report

FDA applicant

Sahar Technologies, Inc.

San Diego, CA3 decisions1997–19980 recalls

FDA records 3 decisions for Sahar Technologies, Inc. (San Diego, CA) from 1997 to 1998: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 8 predicates, 2 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 Sahar Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sahar Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument3decisions

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K964684SoftouchSahar Technologies, Inc. · 19976cite it
  • K971024SoftscanSahar Technologies, Inc. · 19973cite it

What has FDA decided for it lately?

  • K980784SuretouchSahar Technologies, Inc. · 1998
  • K971024SoftscanSahar Technologies, Inc. · 1997
  • K964684SoftouchSahar Technologies, Inc. · 1997

All 3 as Sahar Technologies, Inc. →