FDA applicant

Step UP Skin Laser, LLC

New York, NY1 decision2018–20181 recall

FDA records 1 decision for Step UP Skin Laser, LLC (New York, NY) in 2018: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 1 predicate, 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 Step UP Skin Laser, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2020

2018high 1 (2020) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Step UP Skin Laser, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Step”

FDA records each applicant name separately; these may or may not be the same firm.

S.T.E.P. Orthopaedics, Inc. 1

Step UP Skin Laser, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Step”