Medtek Lighting, LLC's Peacock Tanning, Express Tan Models 1000HT, 2000CT, 2000HT, 3200 are intended to provide ultraviolet light to tan the skin, in male and female users, not under the age of 18 years.

Device Description

The Express Tan 1000HT device is a skin tanning device, wall mounted or used on an accessory stand with a single lighting panel with 10 Cosmedico (T12/F71"/100w) lamps, driven by standard electrical lighting systems at 120 Volts, producing primary UV-A emissions within an enclosed metal (structure) and acrylic (exposure) housing and utilized only with included protective eyewear, as outlined in 21 CFR 1040.20 (c). A digital timer is used to program exposure times. Cabinet dimensions: 85.5" high, 5" deep, 22" wide - when door panels are closed. A digital control timer module is used to program exposure times.

The Express Tan models1600HT/2000CT/2000HT/3200 are skin tanning devices, wall mounted with 4 lighting panels containing an array of a total of 16, 20, or 32 Cosmedico (T12/F71"/100w) lamps, driven by standard electrical lighting systems at 120 Volts, producing UV-A emissions within an enclosed metal (structure) and acrylic (exposure) housing, and that is utilized only with included protective eyewear, as outlined in 21 CFR 1040.20 (c). A digital timer is used to program exposure times. Cabinet dimensions: 92" high, 8" deep, 50" wide - when panels are closed.

AI/ML Overview

This document is a 510(k) premarket notification for a tanning device, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not applicable in the context of an AI/ML device.

The document discusses the substantial equivalence of the "Peacock Tanning, Express Tan Models" to predicate devices based on intended use, technological characteristics, and conformance to special controls and performance standards.

Here's the relevant information that can be extracted from the provided text, adapted to the closest interpretations:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Intended Use Equivalence	The device must have substantially equivalent intended use as predicate devices.	The devices are "intended to provide ultraviolet light to tan the skin, in male and female users, not under the age of 18 years," which is the same as the predicate devices.
Technological Characteristics Equivalence	The device must have substantially equivalent technological characteristics as predicate devices.	The proposed devices (Express Tan models 1000HT/1600HT/2000CT/2000HT/3200) are described as having the "same technological characteristics as the predicate devices" and conforming to special controls. They are wall-mounted or freestanding units with T12/F71"/100w Cosmedico lamps, standard electrical systems (120 Volts), UV-A emissions, enclosed metal/acrylic housing, and digital timers. The primary predicate devices (8920525) are stated as "identical to the proposed Express Tan devices and no differences exist." The secondary predicates (K944015, K871237) have "additional safety features and newer components" but maintain the same technological characteristics.
Performance Standards Compliance	The device must conform to applicable international consensus standards for electrical safety and electromagnetic compatibility (EMC), and performance standards under Section 1040.20 of the Federal Food, Drug, and Cosmetics Act, including radiation limits and protective eyewear transmittance.	The devices "have been tested and conform to international consensus standards": - Electrical Safety: IEC/EN 60601-1:2005 Edition 3 / A1:2012 (General II (ES/EMC)) - EMC: IEC 60601-1-2 Edition 4: 2014 (General II (ES/EMC)) They are also "in compliance with performance standards that have been established for such devices under Section 1040.20 of the Federal Food, Drug, and Cosmetics Act." - Specific performance testing (spectral analysis) was done to measure irradiance to ensure compliance with radiation limits set out in 21 CFR 1040.20. - Specific performance testing was done on the included protective eyewear (goggles) to ensure spectral transmittance did not exceed value limits set out in 21 CFR 1040.20 while allowing visibility for timer reset.
Safety Features	Devices for home use (Models 1000HT/1600HT/2000HT) must include specific safety training, warnings, contraindications, precautions, emergency shut-off, photosensitizing agents list, an exposure log, and a risk acknowledgment certification for consumers.	For home environment models, the sponsor "provides training to the consumer before the product is shipped out." This training includes a User Manual overview, help in determining skin type/exposure schedules, warnings, contraindications, precautions, safety features (e.g., emergency shut-off), a list of photosensitizing agents, a "Tanning Exposure Log," and a "Risk Acknowledgement Certification" form, which consumers must sign.
Age Restriction	The device should be used by individuals not under the age of 18 years.	The devices are "intended to provide ultraviolet light to tan the skin, in male and female users, not under the age of 18 years." The consumer training emphasizes "Tanning bed is not to be used by any person under the age of 18 years."

Since this is not an AI/ML device, the following points are not applicable (N/A):

Sample sized used for the test set and the data provenance: N/A (no AI/ML algorithm or test set in this context)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (no ground truth in the AI/ML sense)
Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A
The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A
The sample size for the training set: N/A
How the ground truth for the training set was established: N/A

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 19, 2016

Medtek Lighting Corp D/b/a Peacock Tanning % Ms. Susan Anthoney-Dewet FDA Consultant Aegis Regulatory, Inc. 2424 Dempster Drive Coralville, Iowa 52241

Re: K152452

Trade/Device Name: Express Tan Models 1000HT/2000CT/2000CT/2000HT/3200 Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet lamp for tanning Regulatory Class: Class II Product Code: LEJ Dated: April 22, 2016 Received: April 25, 2016

Dear Ms. Anthoney-Dewet:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152452

Device Name

Peacock Tanning, Express Tan Models 1000HT/1600HT/2000CT/2000HT/3200

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K152452

Submission Date: August 18, 2015

1. Submitter Information: AEGIS Regulatory, Inc. Susan Anthoney-DeWet 2424 Dempster Drive Coralville, IA 52241 Tel.: 865-982-5552 Email: sue@fdalistingconsultants.com
  For Manufacturer: MedTek Lighting, Inc. d/b/a Peacock Tanning Attn: Mr. Gary Richardson 3 Depot St. Hudson Falls, NY 12839 Tel.: 518-747-3310

General Information: 2.

Regulation Description: Ultraviolet lamp for tanning 2.1
2.2 Common/Usual Name: Booth, Sun Tan
2.3 Proprietary Names: Peacock Tanning, Express Tan models 1000HT/1600HT/2000CT/2000HT/3200
2.4 Classification: Class II
2.5 Classification Number: 878.4635
2.6 Product Code: LEJ

3. Device Description:

Cabinet dimensions: 85.5" high, 5" deep, 22" wide - when door panels are closed. A digital control timer module is used to program exposure times.

The Express Tan models1600HT/2000CT/2000HT/3200 are skin tanning devices, wall mounted with 4 lighting panels containing an array of a total of 16, 20, or 32 Cosmedico

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(T12/F71"/100w) lamps, driven by standard electrical lighting systems at 120 Volts, producing UV-A emissions within an enclosed metal (structure) and acrylic (exposure) housing, and that is utilized only with included protective eyewear, as outlined in 21 CFR 1040.20 (c). A digital timer is used to program exposure times.

Cabinet dimensions: 92" high, 8" deep, 50" wide - when panels are closed.

In order to ensure safety of tanning devices used in the home environment (Models 1000HT/1600HT/2000HT), the sponsor provides training to the consumer before the product is shipped out. Records of this training are kept according to the Sponsor's record keeping procedures.

This training procedure includes:

Overview of the User Manual

Help in determining Skin Type, Effective Exposure schedule based on skin type, . what to do in order to avoid over exposure;
. Going over Warnings, Contraindications, Precautions;
. Going over safety features -i.e. emergency shut-off switch;
Going over list of photosensitizing agents (list in manual); ●
Providing a "Tanning Exposure Log" so that a home consumer may keep track of sessions;
. Tanning bed is not to be used by any person under the age of 18 years;

And finally, having the consumer sign a "Risk Acknowledgement Certification" form. A sample of this form can be found in the proposed amendments to 21 CFR 878.4635 (c) (4)Risk acknowledgement certification, " General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; Proposed Rule, " 80 FR 79493 (22 Dec. 2015).

4. Intended Use:

The Express Tan Models 1000HT, 1600HT, 2000CT, 2000HT, 3200 are intended to provide ultraviolet light to tan the skin in male and female users, not under the age of 18 vears.

5. Predicate Device:

The proposed devices are substantially equivalent to the following predicate devices,

which are currently in safe and effective commerce:

1. Primary Predicate: K Number (NONE)-ACCESSION NUMBER: 8920525, PEACOCK TANNING EXPRESS TAN MODELS 1000/1600/2000/3200 (MEDTEK LIGHTING CORP)
1. K944015 HARPO SUNBED, SUN TANNING MACHINE (HARPO INDUSTRIES) 1994 clearance, Product Code:LEJ

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1. K871237 SUN CAPSULE I & II SUNTANNING BOOTH (SUN CAPSULE, INC) 1987 clearance, Product Code:FTC

6. Substantial Equivalence to Predicate Device:

The primary predicate devices are identical to the proposed Express Tan devices and no differences exist between the devices.

The secondary predicate devices differ from the proposed Express Tan devices in that the proposed devices have additional safety features and newer components but have have the same intended use as the predicate devices; have the same technological characteristics as the predicate devices and conform to the special controls required by the reclassification order.

After an analysis of the safety, indications, intended uses, performance features, design materials, chemical composition, energy source, power output, technological properties, treatment areas, treatment regimes and methods of operation, the manufacturer believes that no significant differences exist between the device and the predicate device listed in section 5 of this summary.

7. Performance Standards:

The Express Tan Models 1000HT, 1600HT, 2000HT, 2000CT, 3200HT have been tested and conform to international consensus standards:

ELECTRICAL SAFETY:

Recognition Number 19-4: IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012 Medical Electrical Equipment -Part 1: General Requirements For Basic Safety And Essential Performance (lec 60601-1:2005, Mod). (General II (ES/EMC))

EMC:

Recognition Number 19-1: IEC 60601-1-2 Edition 4: 2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. (General II (ES/EMC))

These devices have also been tested under and are in compliance with performance standards that have been established for such devices under Section 1040.20 of the Federal Food, Drug, and Cosmetics Act.

Specific performance testing (spectral analysis) was done on these ● devices to measure irradiance to ensure complaince with radiation limits set out in 21 CFR 1040.20.
Specific performance testing was done on the included protective . eyewear (goggles) to ensure spectral transmittance did not exceed the value limits set out in 21 CFR 1040.20 while enabling the user to see

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clearly enough to reset the timer.

Conclusion

Regulation Number and Section

§ 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.

(a)
Identification. A sunlamp product is any device designed to incorporate one or more ultraviolet (UV) lamps intended for irradiation of any part of the living human body, by UV radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning. This definition includes tanning beds and tanning booths. A UV lamp intended for use in sunlamp products is any lamp that produces UV radiation in the wavelength interval of 200 to 400 nanometers in air.(b)
Classification. Class II (special controls). The special controls for sunlamp products and UV lamps intended for use in sunlamp products are:(1) Conduct performance testing that demonstrates the following:
(i) Device meets appropriate output performance specifications such as wavelengths, energy density, and lamp life; and
(ii) Device's safety features, such as timers to limit UV exposure and alarms, function properly.
(2) Demonstrate that device is mechanically safe to prevent user injury.
(3) Demonstrate software verification, validation, and hazard analysis.
(4) Demonstrate that device is biocompatible.
(5) Demonstrate that device is electrically safe and electromagnetically compatible in its intended use environment.
(6)
Labeling —(i)Sunlamp products. (A) The warning statement below must appear on all sunlamp products and must be placed in a black box. This statement must be permanently affixed or inscribed on the product when fully assembled for use so as to be legible and readily accessible to view by the person who will be exposed to UV radiation immediately before the use of the product. It shall be of sufficient durability to remain legible throughout the expected lifetime of the product. It shall appear on a part or panel displayed prominently under normal conditions of use so that it is readily accessible to view whether the tanning bed canopy (or tanning booth door) is open or closed when the person who will be exposed approaches the equipment and the text shall be at least 10 millimeters (height). Labeling on the device must include the following statement: Attention: This sunlamp product should not be used on persons under the age of 18 years. (B) Manufacturers shall provide validated instructions on cleaning and disinfection of sunlamp products between uses in the user instructions.
(ii)
Sunlamp products and UV lamps intended for use in sunlamp products. Manufacturers of sunlamp products and UV lamps intended for use in sunlamp products shall provide or cause to be provided in the user instructions, as well as all consumer-directed catalogs, specification sheets, descriptive brochures, and Web pages in which sunlamp products or UV lamps intended for use in sunlamp products are offered for sale, the following contraindication and warning statements:(A) “Contraindication: This product is contraindicated for use on persons under the age of 18 years.”
(B) “Contraindication: This product must not be used if skin lesions or open wounds are present.”
(C) “Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer.”
(D) “Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
(c)
Performance standard. Sunlamp products and UV lamps intended for use in sunlamp products are subject to the electronic product performance standard at § 1040.20 of this chapter.