510(k) Report

FDA applicant

Niic U.S.A., Inc.

Redwood City, CA16 decisions1988–19900 recalls

FDA records 16 decisions for Niic U.S.A., Inc. (Redwood City, CA) from 1988 to 1990: 16 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and LFL (Instrument, Ultrasonic Surgical). 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 Niic U.S.A., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Niic U.S.A., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Niic U.S.A., 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 Instrument13decisions
  • LFLInstrument, Ultrasonic Surgical2decisions
  • JFLPh Rate Measurement, Carbon-Dioxide1decision

What has FDA decided for it lately?

  • K902133Model IS102S ND:Yag Surgical Laser SystemNiic U.S.A., Inc. · 1990
  • K901205Models IR103,IR107,IR104,IR205 (Add'l Application)Niic U.S.A., Inc. · 1990
  • K902063Niic Model 15 Carbon-Dioxide Surgical Laser SystemNiic U.S.A., Inc. · 1990
  • K901204Expanded Marketing of Models IR104 & IR205 LasersNiic U.S.A., Inc. · 1990
  • K900185Niic Model: DX901 Aspiration SystemNiic U.S.A., Inc. · 1990
  • K896988Niic Laser SystemNiic U.S.A., Inc. · 1990
  • K895581Model: IR205 Articulated Surgical LaserNiic U.S.A., Inc. · 1989
  • K892359Model Number: IR204 CO2 Surgical Laser SystemNiic U.S.A., Inc. · 1989

All 16 as Niic U.S.A., Inc. →