Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262885

308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885): 510(k) cleared for Guangxi Hope Medical Devices Technology Co., Ltd.

Q: How to monitor 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885): 510(k) cleared for Guangxi Hope Medical Devices Technology Co., Ltd. and peer general & plastic surgery records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow records like this one.

308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885): 510(k) cleared for Guangxi Hope Medical Devices Technology Co., Ltd.: 510(k) cleared for Guangxi Hope Medical Devices Technology Co., Ltd. Its amount of 58 is below the median of 138 (15th percentile). Dated 21 days ago, it is in the active follow-up window. Score 36/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 58 · 15th percentile of 414 FDAPulse records · 0.4x the median

Free preview: all 14 published fields of this record are shown below. Locked: 75 related CN FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K262885
Device	308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)
Applicant	Guangxi Hope Medical Devices Technology Co., Ltd.
Specialty / panel	General, Plastic Surgery
Product code	FTC
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-08-17
Decision date	2026-10-14
Review time (days)	58
Third-party review	No
Applicant location	Yulin, CN
amount percentile	15th of 414 (median 138, 0.4x median)
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-14
Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT

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Peer benchmark and outreach value: 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885): 510(k) cleared for Guangxi Hope Medical Devices Technology Co., Ltd. and 76 CN peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

CN FDAPulse records like this one: 76
308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885): 510(k) cleared for Guangxi Hope Medical Devices Technology Co., Ltd.'s amount: 15th percentile of 414 records
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

36 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Fast 58-day review: this device is a strong predicate for similar products.
Posted 21 days ago.

What is the FDAPulse record for 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885): 510(k) cleared for Guangxi Hope Medical Devices Technology Co., Ltd.?

308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885) by Guangxi Hope Medical Devices Technology Co., Ltd. was cleared on 2026-10-14 after 58 days of review.

How does 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885): 510(k) cleared for Guangxi Hope Medical Devices Technology Co., Ltd. compare to other FDAPulse records?

Its amount of 58 is below the median (15th percentile); smaller records often move faster and face less competition. It is 21 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.

308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885) vs. top 3 peers

Organization	Location	Record date
308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885)	CN	2026-10-14
TECAR Therapy Device (TC2000, TC2001) (K252288)	CN	2026-10-13
easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges (K254291)	CN	2026-09-25
Nd	CN	2026-10-13

How to monitor 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885): 510(k) cleared for Guangxi Hope Medical Devices Technology Co., Ltd. and peer general & plastic surgery records

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