510(k) Report

FDA applicant

Strata Skin Sciences, Inc.

Horsham, PA3 decisions2011–20201 recall

FDA records 3 decisions for Strata Skin Sciences, Inc. (Horsham, PA) from 2011 to 2020: 2 510(k) clearances and 1 original PMA approval. Most are in product codes GEX (Powered Laser Surgical Instrument) and OYD (Optical Diagnostic Device For Melanoma Detection). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Strata Skin Sciences, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2011: 12018: 12020: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2011high 1 (2015) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Strata Skin Sciences, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Strata Skin Sciences, 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 Instrument2decisions
  • OYDOptical Diagnostic Device For Melanoma Detection1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K193478XTRAC Momentum Excimer Laser SystemStrata Skin Sciences, Inc. · 20201cites it

What has FDA decided for it lately?

  • K193478XTRAC Momentum Excimer Laser SystemStrata Skin Sciences, Inc. · 2020
  • K181480MMD TipStrata Skin Sciences, Inc. · 2018
  • P090012MelafindStrata Skin Sciences, Inc. · 20111 recall

All 3 as Strata Skin Sciences, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • P090012MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.Apr 2, 2015Class II