510(k) Report

FDA applicant

Biophotas, Inc.

Anaheim, CA6 decisions2013–20230 recalls

FDA records 6 decisions for Biophotas, Inc. (Anaheim, CA) from 2013 to 2023: 6 510(k) clearances. Most are in product codes ILY (Lamp, Infrared, Therapeutic Heating) and OHS (Light Based Over The Counter Wrinkle Reduction). Since 2016 its 510(k)s took a median of 119 days from receipt to decision, against 133 for FDA’s reviews in the same codes and years. Its devices cite 12 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, physical medicine panel, where it files most

How often FDA has decided Biophotas, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2013: 12014: 12016: 12017: 12021: 12023: 1
2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Biophotas, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biophotas, 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?

  • ILYLamp, Infrared, Therapeutic Heating3decisions
  • OHSLight Based Over The Counter Wrinkle Reduction1decision
  • OLIFat Reducing Low Level Laser1decision
  • OAPLaser, Comb, Hair1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 119 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 133 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 24 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.

  • K171323Biophotas CELLUMA3Biophotas, Inc. · 20177cite it
  • K232977Biophotas Celluma CONTOURBiophotas, Inc. · 20234cite it
  • K211038Biophotas Celluma RESTOREBiophotas, Inc. · 20214cite it
  • K131113Biophotas CellumaBiophotas, Inc. · 20143cite it
  • K122237Biophotas LifelightBiophotas, Inc. · 20133cite it
  • K152280BioPhotas Celluma3Biophotas, Inc. · 20163cite it

What has FDA decided for it lately?

  • K232977Biophotas Celluma CONTOURBiophotas, Inc. · 2023
  • K211038Biophotas Celluma RESTOREBiophotas, Inc. · 2021
  • K171323Biophotas CELLUMA3Biophotas, Inc. · 2017
  • K152280BioPhotas Celluma3Biophotas, Inc. · 2016
  • K131113Biophotas CellumaBiophotas, Inc. · 2014
  • K122237Biophotas LifelightBiophotas, Inc. · 2013

All 6 as Biophotas, Inc. →