510(k) Report

510(k) · Cleared

Cleared

DT Controlled Phototherapy Equipment

K233811510(k) SpecialCleared Dec 13, 202314-day reviewClass II21 CFR 878.4630

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

Daavlin Distributing Co. · FTC Light, Ultraviolet, Dermatological

Cleared on Dec 13, 2023 as substantially equivalent to K073587 (Daavlin Distributing Co., 2008) and 1 other predicate after a 14-day review. Its family tree reaches back 2 generations to 2002.

Decided
Dec 13, 2023
Review
14 days
Class
Class II
Product code
FTC
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K022104 (2002). 3 ancestors in all. No later device cites it as a predicate yet.

  1. Root · 2 generations backK022104 Dermapal, Uva 50HZ, Uva 60HZ, Uvb Broad Band 50HZ, Uvb Broad Band…Daavlin Distributing Co. · 2002
  2. 1 generation backK073587 Dermapal with Digital TimerDaavlin Distributing Co. · 2008
  3. This deviceK233811 DT Controlled Phototherapy EquipmentDaavlin Distributing Co. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K022104Dermapal, Uva 50HZ, Uva 60HZ, Uvb Broad Band 50HZ, Uvb Broad Band 60HZ,Uvb…Daavlin Distributing Co.2002—
−1K073587Dermapal with Digital TimerDaavlin Distributing Co.2008—
0 (this device)K233811DT Controlled Phototherapy EquipmentDaavlin Distributing Co.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
202210
FIG. 1 — Lineage of K233811, 2002–2023Source: 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 FTC? 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 FTC device

  1. #1 K242977 308nm Excimer Phototherapy Device (CN-308E…score 14.8 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K073587Dermapal with Digital Timer
Summary page 4
…FTC Panel: General and Plastic Surgery Predicate Devices: Dermapal, 1 Series Phototherapy Equipment 510(k) Number: K073587, K220840 Company: Daavlin Distributing Company The DT Controller is a modernizat…
Daavlin Distributing Co.2008—
*K2208401 Series Phototherapy Equipment
Summary page 4
…FTC Panel: General and Plastic Surgery Predicate Devices: Dermapal, 1 Series Phototherapy Equipment 510(k) Number: K073587, K220840 Company: Daavlin Distributing Company The DT Controller is a modernization of th…
Daavlin Distributing Co.20221

Also cleared against K073587: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 21 years and passes through 1 company; a new generation was cleared every 15.9 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K073587.

How does its category compare?

All FTC devices

FTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · FTC

3in 2025

2007: 42008: 32009: 22010: 12011: 52012: 12013: 12014: 22015: 32016: 12017: 22018: 32019: 22020: 52021: 32022: 12023: 42024: 12025: 32026 (partial year): 4
2007high 5 (2011) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTC

76in 2025

2007: 53 days median2008: 41 days median2011: 125 days median2015: 98 days median2018: 88 days median2020: 237 days median2021: 89 days median2023: 48 days median2025: 76 days median2026 (partial year): 91 days median
2007high 237 (2020) · low 41 (2008)2026

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

Recalls per year · FTC

3so far in 2026, the most since 2007

2008: 12025: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

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

Adverse event reports per year · FTC

8in 2025

2010: 22012: 12013: 12014: 12015: 82016: 22017: 22019: 142020: 42021: 482022: 42023: 52024: 42025: 8
2007high 48 (2021) · low 0 (2007)2025

MAUDE reports naming product code FTC, 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
200745300
200834110
20092—00
20101—02
2011512500
20121—01
20131—01
20142—01
201539808
20161—02
20172—02
201838800
20192—014
2020523704
2021389048
20221—04
202344805
20241—04
202537618
20264913—

What is it indicated for?

The DT Controlled Phototherapy Equipment devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K233811: DT Controlled Phototherapy Equipment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233811

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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