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ProSun International, LLC FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

No warning letters matched by name

Inspections 0 0 OAI

Recalls 3

0 Class I (0%)

Warning letters 0 None on file

510(k) clearances 1 Latest Sep 10, 2018

ProSun International, LLC has 3 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "ProSun International, LLC" is on file.

What these totals cover: FDA records filed under the name "ProSun International, LLC" and its spelling variant "Prosun International".

Latest recall: Z-1176-2019 · Class II · Dec 10, 2018
Latest 510(k): Sep 10, 2018

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	3	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	1	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	0	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

ProSun International, LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

ProSun International, LLC: FDA recall records per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	2	0
2017	0	0	0	1	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent recalls

3 recall records from Dec 2, 2017 to Dec 10, 2018.

Number	Class	Product	Date
Z-1176-2019	Class II	ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN…	Dec 10, 2018
Z-1177-2019	Class II	ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42…	Dec 10, 2018
Z-0319-2018	Class II	Sundream 12 V tanning bed	Dec 2, 2017

Recent 510(k) clearances

1 510(k) clearance on Sep 10, 2018.

K-Number	Device	Date
K181455	ProSun sunlamp products, Luxura sunlamp products	Sep 10, 2018

ProSun International, LLC and the FDA: common questions

Has ProSun International, LLC received an FDA warning letter?

No FDA warning letter addressed to the name "ProSun International, LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has ProSun International, LLC received an FDA Form 483?

FDA has not published a Form 483 for "ProSun International, LLC" in its reading room. FDA publishes some Form 483s, not all of them.

Has ProSun International, LLC had an FDA recall?

Yes. ProSun International, LLC has 3 FDA recalls on record. The most recent started Dec 10, 2018.

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