Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C

K-Number: K091664 · 2009-11-16

Decision Date2009-11-16
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Gsd Tech Co., Ltd.. It received FDA 510(k) clearance on 2009-11-16 under 510(k) number K091664. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C?

GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C is a medical device that received FDA 510(k) clearance on 2009-11-16. The listed applicant is Shenzhen Gsd Tech Co., Ltd.. The 510(k) number is K091664.

When did GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C receive FDA 510(k) clearance?

GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C received FDA 510(k) clearance on 2009-11-16, under 510(k) number K091664.

Who is the listed applicant for GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C?

The FDA 510(k) record lists Shenzhen Gsd Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C?

The FDA product code for GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C is ONF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Shenzhen Gsd Tech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: ONF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.

↑