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

FDA 510(k)

Light based hair removal device

K-Number: K180383 · 2018-05-11

ApplicantShenzhen Gsd Tech Co., Ltd.
Decision Date2018-05-11
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Light based hair removal device is a medical device manufactured by Shenzhen Gsd Tech Co., Ltd.. It received FDA 510(k) clearance on 2018-05-11 under approval number K180383. 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?

Light based hair removal device is a medical device that received FDA 510(k) clearance on 2018-05-11. It is manufactured by Shenzhen Gsd Tech Co., Ltd.. The 510(k) number is K180383.

When was Light based hair removal device approved by the FDA?

Light based hair removal device received FDA 510(k) clearance on 2018-05-11, under approval number K180383.

What company makes Light based hair removal device?

Light based hair removal device is manufactured by Shenzhen Gsd Tech Co., Ltd..

What is the FDA product code for Light based hair removal device?

The FDA product code for Light based hair removal device is OHT.

Related Clinical Trials

NCT07372677 Pocket-X Gel Non-surgical Periodontal Therapy RECRUITING NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT07614373 Virtual Reality-based Mindfulness Training for Mental Health After Stroke NOT_YET_RECRUITING NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING

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.

K191518CO2 Laser System K202827308nm Excimer UV-light Skin Therapy System K213225Diode Laser System GP900A8, Diode Laser System GP900Q8 K230060Light Based Hair Removal Device GP592

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.

↑