The UV Biotek Mobile-Lite model 600 is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)
The UV Biotek Versa-Lite model 1400 is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)

Device Description

The UV Biotek Mobile-Lite model 600 is a lightweight metal box containing six Philips 15-Watt TL-01 nUVB (narrowband UVB) lamps, configured as a suitcase for portability, designed to be placed either on a table or a stand for easy exposure to feet, lower legs, hands and lower arms. A remote control timer module is used to program exposure times and dosages.
The UV Biotek Versa-Lite model 1400 is a phototherapy device, freestanding support with 3 lighting panels containing a total of 14 Philips TL20W/01 (narrowband UVB) lamps. The panels can be used simultaneously or individually, depending on treatment needed. System dimensions: 83" high, 27" deep, and 28" wide - when system panels are in start position.

AI/ML Overview

The described device, UV Biotek Mobile-Lite model 600 and UV Biotek Versa-Lite model 1400, did not undergo a study to demonstrate its performance against specific acceptance criteria. Instead, this 510(k) submission relies on demonstrating substantial equivalence to existing predicate devices.

Therefore, the typical structure for reporting acceptance criteria and study results (as outlined in your request) is not applicable in this case. The provided document is a 510(k) summary, which focuses on comparing the new device to already legally marketed devices rather than presenting data from a de novo clinical or performance study of the new device itself.

Here's an explanation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable. No explicit acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy) are defined in this document for the UV Biotek devices. The "acceptance criteria" for a 510(k) submission seeking substantial equivalence is to demonstrate that the new device is as safe and effective as a predicate device, which is typically achieved through comparison of technological characteristics and intended use.

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

Not Applicable. No specific "test set" or patient data was used to demonstrate the performance of the UV Biotek device itself in a study. The substantial equivalence argument is based on a comparison of device specifications and intended use against predicate devices.

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

Not Applicable. As there was no specific study with a test set requiring ground truth establishment, this information is not relevant.

4. Adjudication Method for the Test Set:

Not Applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. An MRMC study was not conducted as this is not a study evaluating human reader performance with or without AI assistance, but rather a submission for a phototherapy device seeking substantial equivalence to predicate devices.

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

Not Applicable. The device is a phototherapy unit, not an algorithm or AI system.

7. The Type of Ground Truth Used:

Not Applicable.

8. The Sample Size for the Training Set:

Not Applicable. The device is not an AI/ML algorithm that requires a training set.

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

Not Applicable.

Summary of the "Study" (Substantial Equivalence Argument):

The "study" in this context is the Substantial Equivalence Discussion presented in section 6 of the 510(k) summary.

Argument: The manufacturer asserts that the UV Biotek Mobile-Lite model 600 and Versa-Lite model 1400 are substantially equivalent to five predicate devices (K050695, K872649, K933952, K031800, K904427).
Methodology: The comparison is based on:
- Intended Use: Both the proposed devices and the predicate devices are intended for "specific Ultraviolet radiation therapy for diagnosed skin disorders" and are used for "treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)".
- Technological Characteristics: The devices share "the same technological characteristics," including:
  - Design
  - Material (Acrylic patient contact material, "well known and accepted")
  - Energy source (12v Power Adapter, 120v 60 hz)
  - Housing materials and construction (Steele safety shield, UV lamps, timer, googles)
  - Light source (Fluorescent Ultra Violet, specifically Narrowband UVB lamps, e.g., Philips TL-01, TL20W/01, PL-L36W/01)
  - Wavelength Range (311 nm Narrow Band UVB)
  - Power output (various wattages, but within similar ranges for phototherapy)
  - Treatment areas (hand and foot, spot, partial body)
  - Treatment regimes (prescribed by physician)
  - Methods of operation
Conclusion of the Manufacturer: "no significant differences exist between the device and the predicates listed in section 5 of this summary."
FDA Conclusion: The FDA reviewed the submission and concurred, stating the device is "substantially equivalent (for the indications of use stated in the enclosure) to legally marketed predicate devices."

Performance Standards:

While not a direct performance study, the devices are stated to be in compliance with established performance standards for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act. Specifically, they are OSHA/NRTL listed and comply with EN/IEC 60601-1-1 and EN/IEC 60601-1-2, which are general electrical safety and electromagnetic compatibility standards for medical electrical equipment. This demonstrates adherence to safety, but not clinical efficacy in the context of a specific trial.

Summary

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510(k) Summar

K111049

Submission Date: April 10, 2011

1. Submitter Information: AEGIS Regulatory, Inc. - Robert, T. Wagner 1131 Anthem View Lane Knoxville, TN 37922 Tel.: 865-982-5552 Email: bob@fdalistingconsultants.com

For Manufacturer:

MedTek Lighting, Inc. Attn: Mr. Gary Richardson 3 Depot St. Hudson Falls, NY 12839 Tel.: 518-747-3310

2. General Information:

Classification Name: FTC Ultraviolet lamp for dermatologic disorders 2.1
Common/Usual Name: UV Biotek Mobile- Lite and Versa- Lite 2.2
2.3 Proprietary Names: UV Biotek Mobile-Lite model 600 and Versa-Lite model 1400
2.4 Classification: Class II
2.5 Classification Number: 878.4630
2.6 Product Code: FTC

3. Device Description:

The UV Biotek Versa-Lite model 1400 is a phototherapy device, freestanding support with 3 lighting panels containing a total of 14 Philips TL20W/01 (narrowband UVB) lamps. The panels can be used simultaneously or individually, depending on treatment needed. System dimensions: 83" high, 27" deep, and 28" wide - when system panels are in start position.

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4. Intended Use:

The UV Biotek Mobile-Lite model 600 is for individuals who require L specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)
The UV Biotek Versa-Lite model 1400 is for individuals who require 트 specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)

5. Substantial Equivalence to Predicate Device(s):

These devices are substantially equivalent to the following predicate devices, which are currently in safe and effective commerce:

1. K050695 Flex Controlled Phototherapy (Daavlin)
1. K872649 Hand/Foot UVA/UVB (National Biological)
1. K933952 Phototherapeutix 800 (Avex, now Medtek Lighting)
1. K031800 Solrx 500 Series (Solarc)
1. K904427 Panosol II UVB- 206 (National Biological)

Please see attached Predicate Comparison Chart for detailed information.

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Predicate Comparison Char

Device	Company	K" Number	Indications for Use	Power	Treatment Spot Size	Dimensions of Device	Housing Materials and Construction	Energy Source	Treatment Regime	Target Population	Number of Lamps	Model Number	Wattage	Output UVB (W)	Lamp Voltage	Lamp Current	Length of Lamp	Light Source	Wavelength Range	Product Codes
FLEX CONTROLLED PHOTOTHERA Hand/Foot UVA/UVB	Daavlin Distributing Company	K050695	For the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)	120v 60 hz	Hand and Foot	27.5" x 35" (HW) panels fully open	Steele safety shield, UV lamps, timer, googles	12v Power Adapter	Prescribed by physician	People diagnosed with psoriasis, vitiligo, and eczema	8	Narrowband UVB LampsTL 20W/01RS	20w	2.3	57	0.37	24"	Fluorescent Ultra Violet	311 nm (Narrow Band UVB), 305 nm (Broad Band UVB) and 350 nm (UVA)	FTC
National Biological	K872649	For individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.	120v 60 hz	Hand and Foot3-4 Square feet	24"W x 12 ¾"H x 20 "D	Steele safety shield, UV lamps, timer, googles	12v Power Adapter	Prescribed by physician	People diagnosed with skin disorders	8	Narrowband UVB LampsPhilips TL-0120/40/100	2.3/4.6/17.757/104/126.37/.43/.97	24"	Fluorescent Ultra Violet	311 nm (Narrow Band UVB)	FTC
Solrx 500 Series	Solarc	K031800	For individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.	120v 60 hz	Spot, Hand, and Foot2 square feet	15" x 27.5" (HW)	Steele safety shield, UV lamps, timer, googles	12v Power Adapter	Prescribed by physician	People diagnosed with'skin disorders	5	Narrowband UVB LampsPL-L36W/01Lamp Wattage 36w	6.2	106	0.43	24"	Fluorescent Ultra Violet	311 nm (Narrow Band UVB)	FTC

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Page 1Phototherapeutix 800Avex, now Medtek Lighting	MedTek UV Biotek Versa LiteMedtek Lighting	MedTek UV Biotek Mobile LiteMedtek Lighting	Panosol II UVB-206National Biological
K993952	K	K	K904427
For individuals who requirespecific Ultraviolet radiationtherapy for diagnosed skindisorders.	For the treatment of psoriasis,vitiligo, and atopic dermatitis(eczema) on all skin types (I - VI)	For the treatment of psoriasis,vitiligo, and atopic dermatitis(eczema) on all skintypes (I - VI)	For the treatment of psoriasis,vitiligo, and atopic dermatitis(eczema) on all skintypes (I - VI)
120v 60 hzFull Body	120v 60 hzSpot, Hand, and Foot2-3 feet	120v 60 hzSpot, Hand, and Foot2-3 feet	120v 60 hzSpot, Hand, and Foot2-3 feet
3" x 38" x 83" (HWD)	27.5" x 35" (HW) panels fully open	Open- 18" x 34 1/2" x .17 1/2"(HWD)	29-1/2"W x 25-1/2"H x 4-12"D(11-1/2"D with stand)
Steele safety shield, UV lamps,timer, googles	Steele safety shield, UV lamps, timer,googles, stand & wheels	Steele safety shield, UV lamps,timer, googles	Steele safety shield, UV lamps, timer,googles, stand & wheels
12v Power Adapter	12v Power Adapter	12v Power Adapter	12v Power Adapter
Prescribed by physician	Prescribed by physician	Prescribed by physician	Prescribed by physician
People diagnosed with skindisorders	People diagnosed with psoriasis,vitiligo, and eczema	People diagnosed with psoriasis,vitiligo, and eczema	People diagnosed with psoriasis,vitiligo, and eczema
3 Narrowband UVB LampsPhilips TL20W/01Lamp Wattage 20w	6 NarrowBand UVB LampsPhilips TL101Lamp Wattage 15w	14 NarrowBand UVB LampsPhilips TL20W/01Lamp Wattage 20w	8 Narrow Band UVB LampsPhilips TL20W/01Lamp Wattage 20w
2.3570.37	2.3480.2324"	2.3570.3724"	2.3570.3724"
Fluorescent Ultra Violet311 nm (Narrow Band UVB)	Fluorescent Ultra Violet311 nm (Narrow Band UVB)	Fluorescent Ultra Violet311 nm (Narrow Band UVB)	Fluorescent Ultra Violet311 nm (Narrow Band UVB)
ETC	ETC	ETC	ETC

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K. 111049

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6. Substantial Equivalence Discussion:

These devices have the same technological characteristics as the cited predicate devices. Both devices use the same design, material, and energy source as the cited predicates.

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 predicates listed in section 5 of this summary.

Therefore substantial equivalency is requested.

7. Performance Standards:

These devices have been tested under and are in compliance with performance standards that have been established for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act. All electrical and radiological products made by the applicant have been OSHA/NRTL listed, and have received constituent marks and are found to be in compliance with EN/IEC 60601-1-1 and EN/IEC 60601-1-2.

8. Biocompatibility:

The patient contact material on the Mobile Lite and Versa Lite is Acrylic and is the same material used in the cited predicate devices. The biocompatibility of this material is well known and accepted.

9. Sterilization / Use:

The Mobile Lite and Versa Lite is a non-sterile device, and therefore this section is not applicable. Cleaning Instructions are listed in the User's Manual.

Conclusion

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 predicates listed in section 5 of this summary.

Therefore substantial equivalency is requested.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

MAY 2 5 2012

Medtek Lighting Corporation % Aegis Regulatory, Incoporated Mr. Robert Wagner CEO 1131 Anthem View Lane Knoxville, Tennessee 37922

Re: K111049

Trade/Device Name: UV Biotek-Mobile-Lite model 600 and Versa-Lite model 1400 Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: May 14, 2012 Received: May 21, 2012

Dear Mr. Robert Wagner:

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.

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Page 2 - Mr. Wagner

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely yours,

Euid Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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上111049 p. 1 o.t 1

Indications for Use

510(k) Number (if known):

Device Names: UV Biotek- Mobile-Lite model 600 and Versa-Lite model 1400

Indications For Use - Part 878.4630:

The UV Biotek Versa-Lite model 1400 is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nek RP Osl
(Division Sign Off)
Sormkn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of ﺗ

510(k) Number K111049

Regulation Number and Section

§ 878.4630 Ultraviolet lamp for dermatologic disorders.

(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.