The 7 Series Phototherapy Devices are indicated for use to treat diagnosed skin disorders such, as but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.

Device Description

The 7 Series Phototherapy Equipment is a partial-body, ultraviolet light source emitting phototherapy panel. The physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment, as well as the treatment environment. Its nominal size ranges from a 4 lamp no door; 74.5 In X 20 In X 24 In, 75 lbs (189.2 cm X 50.8 cm X 61 cm, 34 kg) to a 12 lamp with doors open; 74.5 In X 39.5 In X 24 In, 129 Lbs. (189.2 cm X 100.3 cm X 61 cm, 58.5 Kg) that is controlled by either an integrated digital timer with an LCD segmented display and four membrane buttons as the interface (the Flex Controller) or a microprocessor controller with an LCD touch screen display (the ClearLink Controller). When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit the prescribed light. The treatment area consists of 4, 6, 8, 10, or 12 100-watt lamps and reflective surfaces configured in a panel. The patient stands in front of the panel during treatment.

AI/ML Overview

This document describes the 7 Series Phototherapy Device, which is a medical device and not an AI or software device. Therefore, the questions related to AI/software performance criteria (such as sample size, ground truth, experts, MRMC studies, or standalone performance) are not applicable.

The performance of the 7 Series Phototherapy Device is established through comparison to a legally marketed predicate device, the ClearLink Phototherapy Equipment (K182215). The submission states that the new device's performance data is "the same as or very similar" to the predicate.

Here's the information available regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria (Implicit by Equivalence to Predicate)	Reported Device Performance (7 Series Phototherapy Device)
Energy Source	Identical to predicate	Identical to predicate
Materials	Identical or similar composition to predicate	Identical or similar composition to predicate
Spectral Output	Same or similar to predicate	Same or similar to predicate
Mode of Operation	Same or similar to predicate	Same or similar to predicate
Labeling	Same or similar to predicate	Same or similar to predicate
Treatment Area	Same or similar to predicate	Same or similar to predicate
Treatment Modality	Same or similar to predicate	Same or similar to predicate
Patient Safety	Same or similar to predicate	Same or similar to predicate
General Operating Principles	Same or similar to predicate	Same or similar to predicate

2. Sample size used for the test set and data provenance:
This information is not applicable as the device's performance is demonstrated through substantial equivalence to a predicate device, rather than a clinical trial with a distinct test set. The submission states that the 7 Series Phototherapy Equipment is constructed with "identical energy sources and materials of identical or similar composition" and that the "lamps and construction used in the production of the predicate devices and the 7 Series phototherapy equipment are the same."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment by experts is described for this type of device submission, as it relies on substantial equivalence to an existing device.

4. Adjudication method for the test set:
Not applicable. No test set requiring adjudication is described.

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:
Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm.

7. The type of ground truth used:
Not applicable. Performance is established by demonstrating substantial equivalence to a predicate device, not by comparing to a "ground truth" in the context of diagnostic accuracy.

8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.

Study Summarized:

The study that proves the device meets the acceptance criteria is a substantial equivalence comparison study to a predicate device (ClearLink Phototherapy Equipment, K182215). The core of the evidence is that the 7 Series Phototherapy Equipment shares fundamental technological characteristics and performance features with the legally marketed predicate.

The 510(k) summary explicitly states that the 7 Series phototherapy equipment is constructed "in the same design configuration as the predicate device, utilizing identical energy sources and materials of identical or similar composition." It further asserts that the "spectral output, mode of operation, labeling, treatment area, treatment modality, patient safety, and general operating principals of the 7 Series phototherapy equipment is the same or similar to those of the predicate device."

This type of study does not involve prospective clinical trials with specific acceptance criteria in the typical sense of measuring efficacy against a clinical outcome. Instead, it demonstrates that the new device performs as safely and effectively as a device already on the market through direct comparison of its technical specifications and principles of operation.

Summary

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November 4, 2021

Daavlin Distributing Co. Michele Thiel Senior Regulatory Affairs Specialist 205 W. Bement Street Bryan, Ohio 43506

Re: K212510

Trade/Device Name: 7 Series Phototherapy Device Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: August 9, 2021 Received: August 10, 2021

Dear Michele Thiel:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212510

Device Name 7 Series Phototherapy Device

Indications for Use (Describe)

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)

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510(K) Summary: K212510

Date of Summary:	November 2, 2021
510(k) Submitter:	Daavlin Distributing Company
Contact Person:	Michele Thiel
	Senior Regulatory Specialist/Management Representative
	Daavlin Distributing Company
	205 West Bement Street
	P.O. Box 626
	Bryan, Ohio 43506Phone: (419) 636-6304 Ext. 207Fax: (419) 636-1739Email: mthiel@daavlin.com
Trade Name:	7 Series Phototherapy Device
Common Name:	Phototherapy Equipment
Regulation Number:	21 CFR 878.4630
Classification Name:	Ultraviolet lamp for dermatologic disorders
Device Class:	Class II
Product Code:	FTC
Panel:	General and Plastic Surgery
Predicate Devices:	ClearLink Phototherapy Equipment
510(k) Numbers:	K182215
Product Code:	FTC
Company:	Daavlin Distributing Company
Device Description:	The 7 Series Phototherapy Equipment is a partial-body,ultraviolet light source emitting phototherapy panel. Thephysician will determine the light spectrum (ultraviolet tovisible), the energy or duration of the treatment, as well as thetreatment environment. Its nominal size ranges from a 4 lamp nodoor; 74.5 In X 20 In X 24 In, 75 lbs (189.2 cm X 50.8 cm X 61cm, 34 kg) to a 12 lamp with doors open; 74.5 In X 39.5 In X 24In, 129 Lbs. (189.2 cm X 100.3 cm X 61 cm, 58.5 Kg) that iscontrolled by either an integrated digital timer with an LCDsegmented display and four membrane buttons as the interface(the Flex Controller) or a microprocessor controller with an LCDtouch screen display (the ClearLink Controller). When theoperator sets the treatment time or the desired dose using theoperator interface located on the control panel, the treatmentbegins by illuminating the lamps which emit the prescribed light.The treatment area consists of 4, 6, 8, 10, or 12 100-watt lampsand reflective surfaces configured in a panel. The patient standsin front of the panel during treatment.
Indications for Use:	The 7 Series Phototherapy Devices are indicated for use to treatdiagnosed skin disorders such, as but not limited to, psoriasis,vitiligo, and atopic dermatitis (eczema) under the direction of aphysician. The population may range from pediatric to geriatric.
Intended Use:	The 7 Series Phototherapy Equipment is intended to be used as apartial body therapeutic device. They are designed to be usedunder the direction of a physician for individuals who requirephototherapy.
Predicate Comparison:	The 7 Series phototherapy equipment is constructed in the samedesign configuration as the predicate device, utilizing identicalenergy sources and materials of identical or similar composition.The spectral output, mode of operation, labeling, treatment area,treatment modality, patient safety, and general operatingprincipals of the 7 Series phototherapy equipment is the same orsimilar to those of the predicate device.

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	Subject Device	Predicate Device
Features	7 Series Phototherapy Equipment	ClearLink PhototherapyEquipment
510(k) Number	This Submission K212510	K182215
Indications forUse	The 7 Series Phototherapy Devicesare indicated for use to treatdiagnosed skin disorders such, asbut not limited to, psoriasis,vitiligo, and atopic dermatitis(eczema) under the direction of aphysician. The population mayrange from pediatric to geriatric.	The ClearLink ControlledPhototherapy Equipment aremedical ultraviolet devices, whichare intended for use, by or under thedirection of a physician, fortherapeutic treatment forindividuals who require ultravioletradiation for diagnosed skindisorders.When equipped with blue lamps theClearLink Controlled PhototherapyEquipment is intended for use forthe treatment of mild to moderateacne vulgaris.
Prescriptive	Yes	Yes
PatientPopulation	Pediatric to Geriatric	Pediatric to Geriatric
Patient Contact	There is no direct patient contactwith the device during treatment –Areas of skin are exposed tocontrolled lamp radiation from adistance of approximately 9 inches(22.86 cm) away.	There is no direct patient contactwith the device during treatment –Areas of skin are exposed tocontrolled ultraviolet and blue lampradiation from a distance ofapproximately 9 inches (22.86 cm)away.

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Features	Subject Device7 Series Phototherapy Equipment	Predicate DeviceClearLink PhototherapyEquipment
510(k) Number	This Submission	K182215
Anatomical Sites	Topical skin treatment	Topical skin treatment
ApplicationEnvironment	Hospital, Clinic, Medical Center,Private Medical Practice, or otherenvironment under the direction ofa physician.	Hospital, Clinic, Medical Center,Private Medical Practice, or OtherProfessional Medical Environmentsunder direction of physician
Materials	Assembled components housed inmetal frame with reflective internalsurfaces and fluorescent lamps	Assembled components housed inmetal frame with reflective internalsurfaces and fluorescent lamps
ManufacturingMethods	Identical	Identical

Performance Standards:	The 7 Series phototherapy equipment performance data is the sameas or very similar to that of the claimed predicate devices. Thelamps and construction used in the production of the predicatedevices and the 7 Series phototherapy equipment are the same. Thedevices materials, construction, treatment modality, patient safety,etc., is exactly the same or similar.
Conclusion:	On the basis of the information provided in this Summary, theDaavlin Distributing Company believes the 7 Series phototherapyequipment is substantially equivalent to the legally commercializedpredicate device.

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.