510(k) Report

FDA applicant

Pharos Life Corporation

Cambridge, CA5 decisions2007–20110 recalls

FDA records 5 decisions for Pharos Life Corporation (Cambridge, CA) from 2007 to 2011: 5 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 7 predicates, 1 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 Pharos Life Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2007: 12008: 12009: 12011: 2
2007high 2 (2011) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pharos Life Corporation’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 Instrument2decisions
  • ILYLamp, Infrared, Therapeutic Heating1decision
  • OHSLight Based Over The Counter Wrinkle Reduction1decision
  • ONEPowered Light Based Non-Laser Surgical Instrument1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 1 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.

  • K080591Tanda Skincare System, Model: PtscsPharos Life Corporation · 20087cite it
  • K090008Tanda Restore, Model PtscsPharos Life Corporation · 20093cite it
  • K110735Tanda Max Otc SystemPharos Life Corporation · 20113cite it
  • K070185Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001Pharos Life Corporation · 20072cite it

What has FDA decided for it lately?

  • K110735Tanda Max Otc SystemPharos Life Corporation · 2011
  • K103415Tanda MaxPharos Life Corporation · 2011
  • K090008Tanda Restore, Model PtscsPharos Life Corporation · 2009
  • K080591Tanda Skincare System, Model: PtscsPharos Life Corporation · 2008
  • K070185Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001Pharos Life Corporation · 2007

All 5 as Pharos Life Corporation →