contac lens info

1. Medical Devices
What is a medical device?
A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related
article, including a component or part, or accessory which is:
 Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them
 Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in
man or other animals
 Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its
primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent
upon being metabolized for the achievement of any of its primary intended purposes.
Import Requirements
Medical devices require FDA processing at all values. Requirements vary depending on the intended use. A medical device coming in
for research will not have the same requirements as a medical device going to a hospital to be used in a medical procedure.
The basic requirements for importing a medical device are:
 Medical device listing number (LST)
 Device Premarket number (PM)
o Class 1 medical devices are exempt
 Manufacturer’s registration number
o Foreign manufacturer (DEV)
o Domestic manufacturer (DDM)
 Device Foreign Exporter Registration number (DFE)
Shipments over $5,000 will require Power of Attorney for the Importer
A radiation emitting medical device may require a 2877 form.
AOC Code Syntax
DEV 1 – 10 Digits
DFE 1 – 10 Digits
LST A, B, C, D, E, L, Q, R + 6 digits
PM #
P, D, H, K, DEN, BK, BH, BM, BR, DK,
BD
+ 6 Digits
N, BP
+ 4 – 6
Digits

2. Use the table provided on the next page to determine what is required for entry based on the intended use.
510(k) Premarket Notification: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Establishment Registration & Device Listing: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm
Radiation Emitting Products: https://www.fda.gov/Radiation-
EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/RegulatedProducts/default.htm
Intended Use Description Requirements
Medical use as a medical device DEV | DFE | LST
Domestic Refurbishing DEV | DFE | LST
Domestically manufactured device that is part of a medical device convenience kit DDM | DFE | LST
Foreign manufactured device that is part of a medical device convenience kit DEV | DFE | LST
Constituent part for use in a medical product regulated under a drug (CBER) application type DEV | DFE | LST
Import of a medical device under enforcement discretion provisions per final guidance
For personal use (shipper and receiver must both be individuals)
For public exhibition, trade show, or display as a non-food product
For charitable organization use DEV | DFE | LST
Component for further manufacturing into a finished medical device
Device component for use in a medical product regulated under a drug (CBER) application type
For repair and re-exportation
For research and development - research and development of a medical device
For research and development - bench testing of nonclinical research use;
Import of a Device Sample for Customer Evaluation
For research and development - clinical investigational use IDE
Import of a device that is US goods returned for refund/overstock (to the manufacturer) DDM | LST
US goods returned for sale to a third party DFE | DDM | LST
Compassionate Use/Emergency Use Device
Import of a single-use device for domestic reprocessing DDM | LST
Import of a multi-use device for domestic reprocessing
Import for Export DEV | DFE | LST
Import for Export of a medical device component DEV | DFE | LST
Other DEV | DFE | LST

3. Please provide the Device Information in the chart(s) below for all devices contained in the shipment along with the devices the information applies
to:
SONOSITE MICROMAXX
ULTRASOUND
WITH CONVEX PROBE
SONOSITE,INC.
21919 30TH DRIVE SE
Bothell, WA 98021 -3904
1 1,850 $
K053069
3032367
U.S.A.

4. Sunglasses/Spectacles
What is a medical device?
A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related
article, including a component or part, or accessory which is:
 Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them
 Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in
man or other animals
 Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its
primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent
upon being metabolized for the achievement of any of its primary intended purposes.
Import Requirements
Spectacles, sunglasses, and optical frames are medical devices and require FDA processing at all values. Requirements vary
depending on the intended use. Sunglasses coming in for research will not have the same requirements as a sunglasses being
imported for resale.
The lens for eyeglasses and/or sunglasses must be certified as impact resistance under 21 CFR Part 801.410.
The basic requirements for importing a sunglasses or eyeglasses are:

5.  Medical device listing number (LST)
 Manufacturer’s registration number
o Foreign manufacturer (DEV)
o Domestic manufacturer (DDM)
 Device Foreign Exporter Registration number (DFE)
 Impact Resistance Certification (IRC)
Shipments over $5,000 will require Power of Attorney for the Importer.
Use the table provided on the next page to determine what is required for entry based on the intended use.
AOC Code Syntax
DEV 1 – 10 Digits
DFE 1 – 10 Digits
LST A, B, C, D, E, L, Q, R + 6 digits

6. Establishment Registration & Device Listing: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm
Sunglasses, Spectacle Frames, Spectacle Lens and Magnifying Spectacles: https://www.fda.gov/MedicalDevices/ucm150001.htm
Certification Statement of Impact Resistance:
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm150002.htm
Intended Use Description Requirements
Medical use as a medical device DEV | DFE | LST
Domestic Refurbishing DEV | DFE | LST
Domestically manufactured device that is part of a medical device convenience kit DDM | DFE | LST
Foreign manufactured device that is part of a medical device convenience kit DEV | DFE | LST
Constituent part for use in a medical product regulated under a drug (CBER) application type DEV | DFE | LST
Import of a medical device under enforcement discretion provisions per final guidance
For personal use (shipper and receiver must both be individuals)
For public exhibition, trade show, or display as a non-food product
For charitable organization use DEV | DFE | LST
Component for further manufacturing into a finished medical device
Device component for use in a medical product regulated under a drug (CBER) application type
For repair and re-exportation
For research and development - research and development of a medical device
For research and development - bench testing of nonclinical research use;
Import of a Device Sample for Customer Evaluation
For research and development - clinical investigational use IDE
Import of a device that is US goods returned for refund/overstock (to the manufacturer) DDM | LST
US goods returned for sale to a third party DFE | DDM | LST
Compassionate Use/Emergency Use Device
Import of a single-use device for domestic reprocessing DDM | LST
Import of a multi-use device for domestic reprocessing
Import for Export DEV | DFE | LST
Import for Export of a medical device component DEV | DFE | LST
Other DEV | DFE | LST

7. Please provide the Device Information in the chart(s) below for all devices contained in the shipment along with the devices the information applies
to. Also please provide the Impact Resistance Certification Documents (Drop Ball) for Spectacles and Sunglasses contained in the shipment:

8. Contact Lenses
Contact lens sales are regulated by both the FDA and the Federal Trade Commission (FTC). Before you buy any contact lenses from
someone other than your eye care professional, the FDA wants you to be a wise consumer. With a valid contact lens prescription, it is
possible to purchase your contact lenses from stores, the Internet, over the phone or by mail.
Decorative contact lenses are medical devices. The U.S. Food and Drug Administration oversees their safety and effectiveness, just
like contact lenses that correct your vision
Import Requirements
Contact Lenses require FDA processing at all values because they are medical devices.
The requirements for importing contact lenses are:
 Medical device listing number (LST)
 Device Premarket number (PM)
 Manufacturer’s registration number
o Foreign manufacturer (DEV)
o Domestic manufacturer (DDM)
 Device Foreign Exporter Registration number (DFE)
 Copy of prescription
Prescription must be valid at the time of entry. Expired prescriptions can’t be used for entry.
‘Colored’ and Decorative Contact Lenses: A Prescription is A Must:
https://www.fda.gov/forconsumers/consumerupdates/ucm275069.htm
Contact Lenses:
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ContactLenses/de
fault.htm
AOC Code Syntax
DEV 1 – 10 Digits
DFE 1 – 10 Digits
LST A, B, C, D, E, L, Q, R + 6 digits
PM #
P, D, H, K, DEN, BK, BH, BM, BR, DK,
BD
+ 6 Digits
N, BP
+ 4 – 6
Digits

9. Contact Lens Prescription:
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ContactLenses/uc
m062345.htm
Please provide the Device Information in the chart(s) below for all devices contained in the shipment along with the devices the information applies
to. Please provide a copy of the patient’s prescription of shipments of contacts travelling from a business to an individual:

10. ADDITIONAL ATTACHMENTS