510(k) Report

FDA applicant

Luvo Medical Technologies, Inc.

Cambridge, CA5 decisions2020–20210 recalls

FDA records 5 decisions for Luvo Medical Technologies, Inc. (Cambridge, CA) from 2020 to 2021: 5 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and PBX (Massager, Vacuum, Radio Frequency Induced Heat). Since 2016 its 510(k)s took a median of 122 days from receipt to decision, against 123 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 4 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 Luvo Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2021

2020: 22021: 3
2020high 3 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Luvo Medical Technologies, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Luvo Medical Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument3decisions
  • PBXMassager, Vacuum, Radio Frequency Induced Heat1decision
  • ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 122 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 123 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 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.

  • K193072Lucent : IPLLuvo Medical Technologies, Inc. · 20202cite it
  • K193446Bare: 808Luvo Medical Technologies, Inc. · 20201cites it
  • K210129RF Thermal SystemLuvo Medical Technologies, Inc. · 20211cites it
  • K203728DarwinLuvo Medical Technologies, Inc. · 20211cites it

What has FDA decided for it lately?

  • K212607DarwinLuvo Medical Technologies, Inc. · 2021
  • K210129RF Thermal SystemLuvo Medical Technologies, Inc. · 2021
  • K203728DarwinLuvo Medical Technologies, Inc. · 2021
  • K193446Bare: 808Luvo Medical Technologies, Inc. · 2020
  • K193072Lucent : IPLLuvo Medical Technologies, Inc. · 2020

All 5 as Luvo Medical Technologies, Inc. →