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FDA 510(k)

Single-use Sterile medical laser fiber

K-Number: K202601 · 2020-12-15

ApplicantRealton (Suzhou) Medical Technology Co., Ltd.
Decision Date2020-12-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Single-use Sterile medical laser fiber is a medical device manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-12-15 under approval number K202601. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single-use Sterile medical laser fiber?

Single-use Sterile medical laser fiber is a medical device that received FDA 510(k) clearance on 2020-12-15. It is manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The 510(k) number is K202601.

When was Single-use Sterile medical laser fiber approved by the FDA?

Single-use Sterile medical laser fiber received FDA 510(k) clearance on 2020-12-15, under approval number K202601.

What company makes Single-use Sterile medical laser fiber?

Single-use Sterile medical laser fiber is manufactured by Realton (Suzhou) Medical Technology Co., Ltd..

What is the FDA product code for Single-use Sterile medical laser fiber?

The FDA product code for Single-use Sterile medical laser fiber is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 40920948 [The internal condom: overview, practical aspects and analysis of the barriers to its use]. Medecine sciences : M/S (2025)

Other Devices by Realton (Suzhou) Medical Technology Co., Ltd.

K202828Surgical Green Laser System K202702FLARE Single-Use Surgical Laser Fiber

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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