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)

dpl IIa Panel

K-Number: K180320 · 2018-04-03

ApplicantLed Technologies, Inc.
Decision Date2018-04-03
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

dpl IIa Panel 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 2018-04-03 under 510(k) number K180320. 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 IIa Panel?

dpl IIa Panel is a medical device that received FDA 510(k) clearance on 2018-04-03. The listed applicant is Led Technologies, Inc.. The 510(k) number is K180320.

When did dpl IIa Panel receive FDA 510(k) clearance?

dpl IIa Panel received FDA 510(k) clearance on 2018-04-03, under 510(k) number K180320.

Who is the listed applicant for dpl IIa Panel?

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 IIa Panel?

The FDA product code for dpl IIa Panel 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.

K223482reVive Light Therapy® Wrinkle and Acne LED DeviceK221430reVive Light Therapy LED Cleansing SystemK210968reVive Light Therapy EssentialsK210965reVive Light Therapy EssentialsK183247dpl FacewareK183118dpl SpotLite

View all 12 devices →

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.

↑