ED 

TECHNOLOGIES 

Lloyd Nelson 

LED Technologies, INC 

6000 Greenwood Plaza Blvd., Suite 110 

Greenwood Village, CO 80111 

Phone: (303) 646-0543 

Email: Inelson@ledtechnologies.com 

Submitted via www.reaulations.aov 

October 3, 2018 

Office of U.S. Trade Representative for Monitoring and Enforcement 

Chair, Section 301 Committee 

Office of the U.S. Trade Representative 

600 17thStreet NW 

Washington, DC 20510 

Re: Request for Exclusion of Ultraviolet or infrared ray apparatus, and parts and accessories 

thereof therapeutic HTS 9018.20.0040, from the determination of Action Pursuant to Section 

301 Investigation into China's Acts, Policies, and Practices Related to Technology Transfer, 

Intellectual Property and Innovation. 

On behalf of LED Technologies, INC ("LEW), we hereby submit this request for Exclusion of Ultraviolet or 

infrared ray apparatus, and parts and accessories thereof therapeutic HTS 9018.20.0040, from the 

determination of Action Pursuant to Section 301 Investigation into China's Acts, Policies, and Practices 

Related to Technology Transfer, Intellectual Property and Innovation, in accordance with the proposal 

by the U.S. Trade Representative ("USTR") to impose a tariff of an additional 25% on certain Chinese 

imports (listed in Annex C). 

"LED" submits this request of exclusion because the Medical Devices imported by LED Technologies 

from China do not violate, breach or infringe on any Practices Related to Technology Transfer, 

Intellectual Property, and Innovation that could affect a US manufacturer. All Intellectual Property is 

owned by LED a US based company. This exclusion in only one of many (9 total submissions) that are 

being submitted for each device model but generally represents the collective effect of these tariffs on 

our company, personal family investment, US consumers and our ability to affect the US economy 

through job growth and reinvestment into returning manufacturing activities and jobs to the US. 99% 

6000 Greenwood Plaza Blvd., Suite 110, Greenwood Village, CO 80111 (303) 646-0543 
of all of our products we manufacture and sell fall under the HTSUS 9018.20.0040 code and the 25% 

tariff has a direct impact to the ability of LED Technologies to continue to provide these medical 

devices that are in strong demand of the US consumer: 

1. Product at Issue: 

a. Medical Device HTSUS 9018.20.0040 

i. Device name: dpl® Spectralite. Device Listing # D303997 

ii. Medical Device Classification under FDA: Class II, Product Code OHS. 

iii. Medical Device authorized to market in USA under FDA Regulation number CFR 

878.4810. 

iv. Medical Device Indication for use as a LED Light Based medical device for the 

treatment of periorbital wrinkles. 

v. This medical device is should under "Over The Counter" (OTC) 

vi. Medical Device marketed name DRX SpectraLite TM Eyecare Pro 

vii. Product Image (See Appendice "A"). 

2. This product was approved for market by the authority of the FDA via premarket notification 

under section 510(k) number K171386, determining that dpi® Spectralite could be legally 

marketed in the USA. 

3. The device in question has been reviewed and authorized for distribution with in the USA by the 

governing US agency (FDA). The device is in US patent filing currently and does not violate, 

steal, infringe on any intellectual property, technology transfer or innovation. The intellectual 

property associated with this device is owned and in control of LED a US based privately held 

company. 

4. We believe that this device should be granted an Exclusion of Tariff imposition of the additional 

25% due to the fact that it does not violate any of the intellectual property of other US 

companies, Device IP is owned by LED a US based company, and the device provides much 

needed health and wellness benefits to the US consumer. 

5. "LEW is classified as a Small Business and is minority family owned and operated in the State of 

Colorado and implementing a plan to open an assembly facility in the Tampa, FL area. 

6. LED will be drastically affected by the additional 25% duty and corresponding reduction in Net 

Income causing a combination of employee reduction (layoffs), significant retail price increases 

that will render these devices out of the price range of the lower and middle class US population 

and a reversal of our expansion plans to begin to bring manufacturing of these device back to 

the US due to lack of capital. LED prides themselves on producing LED Light Based Medical 

Devices economically positioned for ANY US Consumer to afford. The additional 25% duty will 

no longer allow that to be the case and many deserving US consumers will no longer be able to 

afford these devices and receive the care they so deserve. 

7. LED does understand the Government's strategy, intentions and actually supports these actions 

in regards to IP protection and building the US economy and jobs which is why LED is working on 

a plan to bring manufacturing back to the US. In LED's case there is no IP infringement or 

transfer of technology with is device as LED owns all the IP and technology associated with this 

device. 

6000 Greenwood Plaza Blvd., Suite 110, Greenwood Village, CO 80111 (303) 646-0543 
8. The 25% tariff represents over 50% of the company's gross profits and creates severe economic 

harm to our family, employees and company. The tariff does not allow LED Technologies to 

reinvest and grow the company in accordance to the current administration's desire to bring 

manufacturing jobs back to the US. The effects of the 25% tariff imposed on these devices will 

have the following drastic adverse effects to the company, our family's personal investment and 

the US Consumer: 

a. Impact to US Economy and Jobs: Reduced Net Income (Free Cash Flow) to single digit 

percentages results in the following decision reversals: 

i. Reversal #1 - LED Technologies is in the process of reinvesting into US activities 

and job creation by creating an assembly facility in Florida to perform the final 

assembly of our devices. Without the Free Cash Flow to do so we can't move 

forward with the assembly facility and continue to invest into the US economy 

and employment. 

ii. Reversal #2 — Reversing the assembly facility decision in the US means the 

ability to create 20 more jobs which will more than double our current 

employment count is no longer an option. 

iii. Reversal #3 — The assembly facility is the first of a long-term plan to move 

manufacturing to the US. Once LED Technologies has developed the local 

manufacturing expertise, we will only rely on foreign entities for components 

that are not available in the US. This movement back to US manufacturing will 

not occur without the ability to reinvest funds. Single digit profit does not 

allow for this reinvestment long term. 

b. Personal Financial and Employee Impact: LED Technologies, Inc is a Small Family 

Owned Company (less than $10M in Revenue) and we have invested all of our family's 

future in this company. Single digit net income results create an environment that 

would make continued investment and risk unbearable. It would be more financially 

responsible to close the company and invest in the stock market that is performing at 

better than single digit gains. This would be very unfortunate as it would affect 

multiple families economically with the loss of income and employment. 

c. Impact to US Innovation: LED Technologies is the innovation leader in this category. If 

LED Technologies was able to continue operating after the above changes are 

implemented further innovation would be curtailed. This would affect the US 

consumer in a manner that they no longer would be able to have access to these 

health and wellness products in the most effective and beneficial manner. 

d. Impact to US Consumers: If LED Technologies continues with the above adjustments, 

the US consumer will no longer have access to economical Light therapy products. 

The effect of 25% increase in Cost of Goods results in significantly higher retail pricing 

as US retailers operate on a 50-60% margin. These products will now be out of the 

reach of the general public and only available to high net worth individuals like most 

other products in the medical device category. 

e. Negative Impact to Our IP protection: The intent of this tariff is to protect the us 

economy and IP owned by US companies. The Tariff inclusion does not provide any of 

6000 Greenwood Plaza Blvd., Suite 110, Greenwood Village, CO 80111 (303) 646-0543 
these protection elements to LED Technologies as we have complete control over our 

IP and have invested in the appropriate measures to protect it. The tariff conversely 

creates a punishment effect on LED Technologies in the form of an undue increase in 

cost of goods, employment loss, dramatic price increases to the US consumer, 

potential business closure, US innovation reduction and reduced manufacturing 

reinvestment in the US due to a 50% reduction in Net Income. LED Technologies 

requests this exclusion from the tariff in order to continue to operate and reinvest 

into the US economy and employment strategy of the current administration rather 

than look to find more economically feasible foreign opportunities just to continue to 

operate. 

9. The US Customs and Boarder Protection already administers these devices on an individual basis 

through the current Entry Documentation process and UDI identification. The Devices 

requested for Exclusion are identified by the FDA as Device Listing # D303997. 

10. This device can't be manufactured in the US or another country due to the nature of the 

customized molds designed for specific equipment located at our foreign factory partners. LED 

has over $1,000,000 USD invested in various molds associated with this equipment and 

transferring these to the US or another country would be cost prohibited. LED utilizes two 

factories located in Shenzhen, China which are both owned and operated by non-Chinese 

entities. Both factories produce exclusively for LED and there is no transfer or theft of IP or 

other technology. LED Technologies has invested in both US Patents and Chinese Manufacturing 

Patents to prevent the counterfeit production of our devices. To date we have not experienced 

any type of counterfeit production or patent infringements due to our current IP strategy. 

11. This Medical Device requesting Exclusion does not impact the aMIC 2025" or any other Chinese 

Industrial Program as this Device is approved for sale in the US through the US agency (FDA) and 

our factories are exclusive to LED Technologies a US Company which sells 90% of our products 

within the 50 United States of America. 

LED Technologies thanks you for your consideration and granting of an exclusion to these tariffs so we 

may continue to reinvest into the US economy and job creation. 

Sincerely, 

LI •yd elson 

'resident/CEO 

LED Technologies, INC 

6000 Greenwood Plaza Blvd., Suite 110, Greenwood Village, CO 80111 (303) 646-0543 
APPENDICE A 

Device Imagery 

6000 Greenwood Plaza Blvd., Suite 110, Greenwood Village, CO 80111 (303) 646-0543