510(k) Report

FDA applicant

R2 Dermatology,Inc

San Ramon, CA2 decisions2016–20170 recalls

FDA records 2 decisions for R2 Dermatology,Inc (San Ramon, CA) from 2016 to 2017: 2 510(k) clearances. All are in product code GEH (Unit, Cryosurgical, Accessories). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “R2 Dermatology”.

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 R2 Dermatology,Inc’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2016: 12017: 1
2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — R2 Dermatology,Inc by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like R2 Dermatology,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?

  • GEHUnit, Cryosurgical, Accessories2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K171398Dermal Cooling SystemR2 Dermatology,Inc · 20171cites it
  • K161480R2 Dermal Cooling SystemR2 Dermatology · 20161cites it

What has FDA decided for it lately?

  • K171398Dermal Cooling SystemR2 Dermatology,Inc · 2017
  • K161480R2 Dermal Cooling SystemR2 Dermatology · 2016

The one decision as R2 Dermatology,Inc →The one decision as R2 Dermatology →