510(k) Report

FDA applicant

Biorenew Labs, LLC

Hermosa Beach, CA2 decisions2014–20150 recalls

FDA records 2 decisions for Biorenew Labs, LLC (Hermosa Beach, CA) from 2014 to 2015: 2 510(k) clearances. Most are in product codes OLP (Over-The-Counter Powered Light Based Laser For…) and OHS (Light Based Over The Counter Wrinkle Reduction). Its devices cite 3 predicates, 0 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 Biorenew Labs, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014: 12015: 1
2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Biorenew Labs, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biorenew Labs, LLC’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?

  • OLPOver-The-Counter Powered Light Based Laser For Acne1decision
  • OHSLight Based Over The Counter Wrinkle Reduction1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC · 20151cites it
  • K132613Sonilase Light Therapy DeviceBiorenew Labs, LLC · 20141cites it

What has FDA decided for it lately?

  • K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC · 2015
  • K132613Sonilase Light Therapy DeviceBiorenew Labs, LLC · 2014

All 2 as Biorenew Labs, LLC →