510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LED Technologies, Inc.

Largo, FL, US

LED TECHNOLOGIES, INC. appears in FDA device records in Largo, FL. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
15
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 15 510(k) clearances for LED Technologies, Inc. between 2008 and 2022. The busiest year on record is 2018, with 4. The most recent is 2022, with 2.

Clearances by year, as a table
510(k) clearance decisions for LED Technologies, Inc., by decision year
YearClearances
20081
20101
20151
20172
20184
20192
20212
20222
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K223482reVive Light Therapy® Wrinkle and Acne LED DeviceOHSSubstantially Equivalent
K221430reVive Light Therapy LED Cleansing SystemOHSSubstantially Equivalent
K210968reVive Light Therapy EssentialsOLPSubstantially Equivalent
K210965reVive Light Therapy EssentialsOHSSubstantially Equivalent
K183247dpl FacewareOHSSubstantially Equivalent
K183118dpl SpotLiteOLPSubstantially Equivalent
K180447reVive Light Therapy LED Cleansing SystemOLPSubstantially Equivalent
K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemOHSSubstantially Equivalent
K180320dpl IIa PanelOHSSubstantially Equivalent
K172662reVive PerioralOHSSubstantially Equivalent
K171386dpl SpectraLiteOHSSubstantially Equivalent
K171390dpl II PanelOHSSubstantially Equivalent
K141181NUVE FOR WRINKLES, DPL NUVE FOR WRINKLESOHSSubstantially Equivalent
K101382DPL NUVEOHSSubstantially Equivalent
K081570DPL THERAPY SYSTEMILYSubstantially Equivalent

Registered establishments

FDA registered establishments for LED Technologies, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30159742803012420078LED TECHNOLOGIES, INC.11701 Belcher Rd S., Suite 110, Largo, FL 33773 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1581-2016reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pain associated with muscle spasms, arthritis, general aches and strains.Incorrect Power Supply in the package, rendering the device inoperable.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain