510(k) Report

510(k) · Cleared

Cleared

Cosmedico Ultraviolet Lamps of Various Models

K152273510(k) TraditionalCleared Oct 30, 201579-day reviewClass II21 CFR 878.4635

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cosmedico Light, Inc. · LEJ Booth, Sun Tan

Cleared on Oct 30, 2015 after a 79-day review. The FDA summary names no predicate by number. 1 later device descends from it.

Decided
Oct 30, 2015
Review
79 days
Class
Class II
Product code
LEJ
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared201620182020202220242026
  1. This deviceK152273 Cosmedico Ultraviolet Lamps of Various ModelsCosmedico Light, Inc. · 2015
  2. Descendant · cites it directly · 0 of its ownK180581 UV Lamps for Sunlamp ProductsFeilo Sylvania Germany GmbH · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K180581UV Lamps for Sunlamp ProductsFeilo Sylvania Germany GmbH · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K152273Cosmedico Ultraviolet Lamps of Various ModelsCosmedico Light, Inc.2015—
+1K180581UV Lamps for Sunlamp ProductsFeilo Sylvania Germany GmbH2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K152273, 2015–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LEJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LEJ device

  1. #1 K221523 Tanning Lampscore 5.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K180581UV Lamps for Sunlamp ProductsFeilo Sylvania Germany GmbH20180

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K180581 (Feilo Sylvania Germany GmbH, 2018) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LEJ devices

LEJ Booth, Sun Tan: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · LEJ

1in 2023

2009: 12015: 92016: 112017: 12018: 62019: 32022: 12023: 1
2007high 11 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LEJ

105in 2019

2015: 102 days median2016: 247 days median2018: 106 days median2019: 105 days median
2007high 247 (2016) · low 102 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LEJ

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LEJ

1in 2025

2008: 12009: 12011: 22012: 292013: 42014: 92015: 42017: 92018: 42019: 12020: 32022: 42023: 22024: 22025: 1
2007high 29 (2012) · low 0 (2007)2025

MAUDE reports naming product code LEJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20091—01
20100—00
20110—02
20120—029
20130—04
20140—09
2015910204
20161124700
20171—19
2018610604
2019310501
20200—03
20210—00
20221—04
20231—02
20240—02
20250—01
20260—0—

What is it indicated for?

INTENDED USE: This ultraviolet lamp is intended for use in sunlamp products for tanning of the human skin.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K152273: Cosmedico Ultraviolet Lamps of Various Models.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152273

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026