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FDA 510(k)

LASERTOUCHONE (OTC)

K-Number: K100116 · 2010-04-15

ApplicantLaser Health Technologies, LLC
Decision Date2010-04-15
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LASERTOUCHONE (OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Laser Health Technologies, LLC. It received FDA 510(k) clearance on 2010-04-15 under 510(k) number K100116. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASERTOUCHONE (OTC)?

LASERTOUCHONE (OTC) is a medical device that received FDA 510(k) clearance on 2010-04-15. The listed applicant is Laser Health Technologies, LLC. The 510(k) number is K100116.

When did LASERTOUCHONE (OTC) receive FDA 510(k) clearance?

LASERTOUCHONE (OTC) received FDA 510(k) clearance on 2010-04-15, under 510(k) number K100116.

Who is the listed applicant for LASERTOUCHONE (OTC)?

The FDA 510(k) record lists Laser Health Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASERTOUCHONE (OTC)?

The FDA product code for LASERTOUCHONE (OTC) is NUH.

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.

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Other records listing Laser Health Technologies, LLC 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.

K083822LASER TOUCHONE

Related Devices (Code: NUH)

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.

K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Shenzhen Osto Medical Technology Co.,LtdK260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K251958VEINOPLUS BackDynapulse Medical

Official Source

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

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