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FDA 510(k)

dpl SpectraLite

K-Number: K171386 · 2017-08-07

ApplicantLed Technologies, Inc.
Decision Date2017-08-07
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

dpl SpectraLite is the device name listed in this FDA 510(k) record. The listed applicant is Led Technologies, Inc.. It received FDA 510(k) clearance on 2017-08-07 under 510(k) number K171386. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the dpl SpectraLite?

dpl SpectraLite is a medical device that received FDA 510(k) clearance on 2017-08-07. The listed applicant is Led Technologies, Inc.. The 510(k) number is K171386.

When did dpl SpectraLite receive FDA 510(k) clearance?

dpl SpectraLite received FDA 510(k) clearance on 2017-08-07, under 510(k) number K171386.

Who is the listed applicant for dpl SpectraLite?

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

What is the FDA product code for dpl SpectraLite?

The FDA product code for dpl SpectraLite is OHS.

Other records listing Led Technologies, Inc. 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.

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Related Devices (Code: OHS)

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.

K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading LimitedK261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLCK2605985 Wavelength LED Facemask (TN2508)iSMART Developments, Ltd.

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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