The Suncapsule Tanning Booth devices (All Models) are intended to provide ultraviolet light exposure to male and female users over the age of 18 years to produce a tanning response in the skin.

Device Description

All Sun Capsule models are stand up booths utilizing UV fluorescent lamps arranged on upright walls in a hexagon pattern. Some models also include an optional changing booth. Standard industry construction materials are used including steel trusses, particle board, lighting components, pop rivets, etc. There are no unique materials other than the lamps which use length and diameter combinations that are unique to the tanning industry and not used for general lighting.

The number, length, and operating parameters of the lamps of each model differ in order to shorten or lengthen the exposure time desired by the purchaser. Each of the six walls constitutes a lighting fixture containing the lamps, sockets, ballast, wire, connectors and components associated with the lamp sizes required for the particular model. There are no other differences between the models.

A digital control timer module is used to program exposure times and the booths are utilized only with included protective eyewear, as outlined in 21 CFR 1040.20 (c).

AI/ML Overview

This document is a 510(k) summary for a medical device called "Suncapsule Tanning Booth Devices (All Models)". This device is an ultraviolet lamp for tanning, classified as Class II. The document details the device, its intended use, and its substantial equivalence to predicate devices.

Here's an analysis of the provided text, particularly focusing on the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Electrical Safety	Conforms to IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012
Electromagnetic Compatibility (EMC)	Conforms to IEC 60601-1-2 Edition 4: 2014
Safety-Specific to Sunlamp Products	Conforms to UL 482: Standard for Portable Sun/Heat Lamps Edition: 9
Radiation Limits	Complies with 21 CFR 1040.20 (Performance Standard For Sunlamp products and ultraviolet lamps intended for use in sunlamp products)

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Specific performance testing (spectral analysis) data is submitted in this application for each device that measured irradiance to ensure compliance with radiation limits set out in 21 CFR 1040.20."

Test Set Sample Size: The term "each device" implies that each model of the Sun Capsule Tanning Booth Devices underwent testing to measure irradiance. The specific number of individual units tested for each model is not provided.
Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin. However, the testing was conducted by the manufacturer to demonstrate compliance with national and international standards, suggesting it was an internal validation effort.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The device's performance is measured against engineering and regulatory standards (e.g., IEC, UL, 21 CFR 1040.20), not against a human-established ground truth like expert consensus on medical images.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The performance criteria are objective measurements against established engineering and regulatory standards, not subjective interpretations requiring adjudication.

5. 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

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers in this document. This device is a tanning booth, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. The device is a physical product (tanning booth) and its performance is measured based on its physical properties and emissions, not an algorithm's standalone performance.

7. The Type of Ground Truth Used

The ground truth used for this device's acceptance is based on:

Established national and international consensus standards: IEC/EN 60601-1, IEC 60601-1-2, UL 482.
FDA performance standards: 21 CFR 1040.20, specifically for radiation limits and irradiance measurements.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device is not an AI/ML model that requires a training set. Its performance is based on engineering and design specifications and physical testing.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/provided as there is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized caduceus with three intertwined snakes and a staff, representing health and medicine.

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

March 4, 2016

Sun Capsule, Inc. Ms. Susan Anthoney-DeWet Aegis Regulatory, Inc. 2424 Dempster Drive Coralville, IA 52241

Re: K152238 Trade/Device Name: Sun Capsule 60/220/1.9/6 Sun Capsule 60/225/2.0/6 Sun Capsule 54/225/2.0/5.5 Sun Capsule 54/220/1.9/5.5 Sun Capsule 54/200/1.8/6 Sun Capsule 54/160/1.8/6 Sun Capsule 49/225/2.0/5.5 Sun Capsule 49/220/1.9/5.5 Sun Capsule 48/220/1.9/6 Sun Capsule 48/200/1.8/6 Sun Capsule 48/180/1.9/6 Sun Capsule 48/160/1.8/6 Sun Capsule 44/180/2.0/5.5 Sun Capsule 44/180/1.9/5.5 Sun Capsule 39/180/1.9/5.5 Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet lamp for tanning Regulatory Class: Class II Product Code: LEJ Dated: February 26, 2016 Received: March 3, 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

{1}------------------------------------------------

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 (reporting of medical device-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" (21CFR 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152238

Device Name

Suncapsule Tanning Booth Devices(All Models)

Indications for Use (Describe)

The Suncapsule Tanning Booth devices (All Models) are intended to provide ultraviolet light exposure to male and female users over the age of 18 years to produce a tanning response in the skin.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

K152238

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: Sun Capsule, Inc. Thomas P. Holland President 1600 Osgood Street, Suite 2006 North Andover, MA 01845 Phone: 800-272-8267 Ext 200 Phone: 978-655-3076 E-mail: THolland@suncapsule.com

2. General Information:

Requlation Description: Sunlamp products and ultraviolet lamps intended for 2.1 use in sunlamp products.

2.2 Common/Usual Name: Booth, Sun Tan
Proprietary Names: 2.3

Sun Capsule 60/160/1.8/6 Sun Capsule 60/220/1.9/6 Sun Capsule 60/225/2.0/6 Sun Capsule 54/225/2.0/5.5 Sun Capsule 54/220/1.9/5.5 Sun Capsule 54/200/1.8/6 Sun Capsule 54/160/1.8/6 Sun Capsule 49/225/2.0/5.5 Sun Capsule 49/220/1.9/5.5 Sun Capsule 48/220/1.9/6 Sun Capsule 48/200/1.8/6 Sun Capsule 48/180/1.9/6 Sun Capsule 48/160/1.8/6 Sun Capsule 44/180/2.0/5.5 Sun Capsule 44/180/1.9/5.5 Sun Capsule 39/180/1.9/5.5

{4}------------------------------------------------

2.4 Classification: Class II, Special Controls
2.5 Classification Number: 878.4635
2.6 Product Code: LEJ

3. Device Description:

A digital control timer module is used to program exposure times and the booths are utilized only with included protective eyewear, as outlined in 21 CFR 1040.20 (c).

4. Intended Use:

The Suncapsule Tanning Booth devices (All Models) are intended to provide ultraviolet light exposure to male and female users over the age of 18 years to produce a tanning response in the skin.

5. Predicate Device:

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

which are currently in safe and effective commerce:

Primary Predicate Device: *All devices listed in Section 2.3 of this 510k Summary-

ACCESSION NUMBER: 1531591-000.

Secondary Predicate Devices:

1. Sun Capsule Tanning Booths 1& 2, Suncapsule, Inc, K871237: 1987
  *All of the devices included in this submission existed and were legally marketed prior to September 2, 2014. FDA accession numbers are included in this submission.

Federal Register Volume 79, Number 105 (Monday, June 2, 2014)]"Any sunlamp product or UV lamp intended for use in a sunlamp product legally marketed on or before September 2, 2014 ....can be used as a predicate device in a 510(k)".

{5}------------------------------------------------

6. Substantial Equivalence to Predicate Device:

The primary predicate devices are identical to the proposed Sun Capsule Tanning Booth devices and no differences exist between the devices.

The secondary predicate device differs from the proposed Sun Capsule Tanning Booth devices in that the proposed devices have additional safety features and newer components but have the same intended use as the predicate device; have the same technological characteristics as the predicate device 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 Sun Capsule Tanning Booth devices (All Models) have been tested and conform to national and international consensus standards:

NATIONAL AND 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))

SAFETY-SPECIFIC TO SUNLAMP PRODUCTS :

No recognition number found.

UL 482: Standard for Portable Sun/Heat Lamps Edition: 9
Devices have also been tested under and are in compliance with:

FDA PERFORMANCE STANDARDS:

21 CFR 1040.20 (Performance Standard For Sunlamp products and . ultraviolet lamps intended for use in sunlamp products)

{6}------------------------------------------------

Specific performance testing (spectral analysis) data is submitted in this application for each device that measured irradiance to ensure compliance with radiation limits set out in 21 CFR 1040.20.

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.