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FDA 510(k)

Light Based Hair Removal Device GP592

K-Number: K230060 · 2023-03-03

ApplicantShenzhen Gsd Tech Co., Ltd.
Decision Date2023-03-03
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Light Based Hair Removal Device GP592 is a medical device manufactured by Shenzhen Gsd Tech Co., Ltd.. It received FDA 510(k) clearance on 2023-03-03 under approval number K230060. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Light Based Hair Removal Device GP592?

Light Based Hair Removal Device GP592 is a medical device that received FDA 510(k) clearance on 2023-03-03. It is manufactured by Shenzhen Gsd Tech Co., Ltd.. The 510(k) number is K230060.

When was Light Based Hair Removal Device GP592 approved by the FDA?

Light Based Hair Removal Device GP592 received FDA 510(k) clearance on 2023-03-03, under approval number K230060.

What company makes Light Based Hair Removal Device GP592?

Light Based Hair Removal Device GP592 is manufactured by Shenzhen Gsd Tech Co., Ltd..

What is the FDA product code for Light Based Hair Removal Device GP592?

The FDA product code for Light Based Hair Removal Device GP592 is OHT.

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Related PubMed Literature

PMID: 42173550 Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care. BMJ health & care informatics (2026) PMID: 42107714 Global approval and certification of ophthalmic AI devices: A comparative regulatory perspective. Asia-Pacific journal of ophthalmology (Philadelphia, Pa.) (2026) PMID: 41860549 FDA-Regulated AI-Enabled Medical Devices With Pediatric Indications. JAMA network open (2026) PMID: 41857339 Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority. NPJ digital medicine (2026)

Other Devices by Shenzhen Gsd Tech Co., Ltd.

K180383Light based hair removal device K191518CO2 Laser System K202827308nm Excimer UV-light Skin Therapy System K213225Diode Laser System GP900A8, Diode Laser System GP900Q8

Related Devices (Code: OHT)

K162231iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expertCyden Limited K161089sensiLight MiniEl Global Trade, Ltd. K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited K172181micro IPLEl Global Trade, Ltd. K171433Silk'n InfinityHome Skinovations , Ltd. K170269Hee HR MiniOriental Inspiration Limited

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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