510(k) Report

FDA applicant

Thermolase Corp.

San Diego, CA3 decisions1995–19990 recalls

FDA records 3 decisions for Thermolase Corp. (San Diego, CA) from 1995 to 1999: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). 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 Thermolase Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Thermolase Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Thermolase Corp. 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

Who builds on its devices?

Later devices cite its devices 12 times; 0 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.

  • K950019Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100Thermolase Corp. · 19958cite it
  • K971207Softlight Q-Switched (ND:Yag) LaserThermolase Corp. · 19984cite it

What has FDA decided for it lately?

  • K993209Softlight Q-Switched ND: Yag Laser with Optional Beam-Shrinking Handpiece AccessoryThermolase Corp. · 1999
  • K971207Softlight Q-Switched (ND:Yag) LaserThermolase Corp. · 1998
  • K950019Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100Thermolase Corp. · 1995

All 3 as Thermolase Corp. →