K Number

Device Name

DT Controlled Phototherapy Equipment

Manufacturer

Daavlin Distributing Co.

Date Cleared

2023-12-13

(14 days)

Product Code

FTC

Regulation Number

878.4630

Intended Use

The DT Controlled Phototherapy Equipment 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 DT Controller is a modernization of the DermaPal Controller (510(k) K073587). Like its predicate, the DT Controller is designed to turn a phototherapy device on and off based on time. It is designed to be installed in a wider family of devices. It uses the same 4 button UI with a larger backlit screen for better readability and is based on a more commercially available PIC16 processor. A modification to the way a prescription is entered was done to harmonize the process across different devices.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K073587, K220840

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states it is a modernization of a predicate device and controls the phototherapy based on time, not complex algorithms or data analysis. There are no mentions of AI, ML, image processing, or training/test sets.

Therapeutic

Yes
The device is indicated for use to treat diagnosed skin disorders, which is a therapeutic purpose.

Diagnostic

The device is indicated for treating diagnosed skin disorders using phototherapy, not for diagnosing them. It functions by controlling a phototherapy device (turning it on and off) based on time.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "controller" designed to be "installed in a wider family of devices" and uses a "PIC16 processor," indicating it is a hardware component, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to treat diagnosed skin disorders using phototherapy. IVDs are used to diagnose diseases or conditions by examining specimens from the human body (like blood, urine, tissue).
Device Description: The device is a controller for phototherapy equipment, designed to turn the light on and off based on time. This is a therapeutic function, not a diagnostic one.
Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information.

The device is clearly a therapeutic device used for treating skin conditions with light.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

FTC

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Topical skin treatment

Indicated Patient Age Range

Pediatric to Geriatric

Intended User / Care Setting

Hospital, Clinic, Medical Center, Private Medical Practice, or other environment under the direction of a physician.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Functional testing in the form of Black Box testing was completed on the DT controller and the functions appear to be working per the specifications.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K073587, K220840

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 13, 2023

Daavlin Distributing Co. Michele Thiel Regulatory Manager 205 West Bement Street Bryan, Ohio 43506

Re: K233811

Trade/Device Name: DT Controlled Phototherapy Equipment Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: November 29, 2023 Received: November 29, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

approvals in the device master record (21 CFR 820.181).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Jianting Wang Digitally Digitally signed by Jianting Date: 2023.12.13 16:38:26 -2 -05'00'

For Tanisha Hithe 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

Indications for Use

510(k) Number (if known) K233811

Device Name DT Controlled Phototherapy Equipment

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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Image /page/3/Picture/0 description: The image shows the word "Daavlin" in a stylized font. The first two letters, "Da", are in a teal color, while the rest of the letters are in a light blue color. Below the word "Daavlin" is the phrase "Let's Be Clear" in a smaller, sans-serif font.

Special 510k Summary

510(K) Summary:
Date of Summary:	November 28, 2023
510(k) Submitter:	Daavlin Distributing Company
Contact Person:	Michele Thiel
	Regulatory Manager
	Daavlin Distributing Company
	205 West Bement Street
P.O. Box 626
Bryan, Ohio 43506
Phone: (419) 636-6304 Ext. 207
Fax: (419) 636-1739
Email: mthiel@daavlin.com
	Trade Name:	DT Controlled Phototherapy Equipment
Common Name:	Phototherapy Equipment
510(k) Number:	K233811
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:	Dermapal, 1 Series Phototherapy Equipment
510(k) Number:	K073587, K220840
Company:	Daavlin Distributing Company
Device Description:	The DT Controller is a modernization of the DermaPal Controller (510(k)
K073587). Like its predicate, the DT Controller is designed to turn a
phototherapy device on and off based on time. It is designed to be installed in a
wider family of devices. It uses the same 4 button UI with a larger backlit screen
for better readability and is based on a more commercially available PIC16
processor. A modification to the way a prescription is entered was done to
harmonize the process across different devices.
	Indications for Use:	The DT Controlled Phototherapy Equipment are medical ultraviolet devices,
which are intended for use, by or under the direction of a physician, for
therapeutic treatment for individuals who require ultraviolet radiation for
diagnosed skin disorders.
		Intended Use:	The DT Controlled Phototherapy Equipment 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
			Predicate Comparison:
			Functional testing in the form of Black Box testing was completed on the DT
controller and the functions appear to be working per the specifications.

Image /page/4/Picture/0 description: The image shows the logo for Daavlin. The word "Daavlin" is written in a stylized font, with the first half of the word in a light teal color and the second half in a light blue color. Below the word "Daavlin" is the phrase "Let's Be Clear" in a smaller, sans-serif font.

	Subject Device	Predicate Device	Predicate Device
Features	DT Controlled	Dermapal	1 Series Controlled
	Phototherapy Equipment		Phototherapy Equipment
510(k) Number	This Submission	K073587	K220840
Picture	Image: DT Controlled Phototherapy Equipment	Image: Dermapal	Image: 1 Series Controlled Phototherapy Equipment
Indications for
Use	The DT Controlled
Phototherapy Equipment
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.	Intended for use, by or
under the direction of a
physician, for the
treatment of localized
cases of psoriasis and
vitiligo.	The 1 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.
Prescriptive	Yes	Yes	Yes
Patient
Population	Pediatric to Geriatric	Dermatology Patients	Pediatric to Geriatric

Image /page/5/Picture/0 description: The image shows the logo for Daavlin. The word "Daavlin" is written in a stylized font, with the first two letters in a light green color and the rest in a light blue color. Below the name is the phrase "Let's Be Clear" in a smaller, sans-serif font.

	Subject Device	Predicate Device	Predicate Device
Features	DT Controlled
Phototherapy Equipment	Dermapal	1 Series Controlled
Phototherapy Equipment
510(k) Number	This Submission	K073587	K220840
Patient Contact	The DT Controlled
Phototherapy Equipment
device is designed have the
areas of skin to be exposed
to controlled lamp
radiation by placing the
area on the Acrylic, or
from a distance of
approximately 9 inches
(22.86 cm) away.	N/A	The 1 Series device is
designed have the areas of
skin to be exposed to
controlled lamp radiation
by placing the area on the
Acrylic, or from a distance
of approximately 9 inches
(22.86 cm) away.
Anatomical Sites	Topical skin treatment	Topical local skin
treatment	Topical skin treatment
Application
Environment	Hospital, Clinic, Medical
Center, Private Medical
Practice, or other
environment under the
direction of a physician.	N/A	Hospital, Clinic, Medical
Center, Private Medical
Practice, or other
environment under the
direction of a physician.
Materials	Face of the controller is a
plastic overlay. The
controller is a PC Board
populated with the
processors, power supply,
display and other standard
electronic parts.	Assembled components
housed in plastic case	Assembled components
housed in plastic frame
with reflective internal
surfaces and fluorescent
lamps
Manufacturing
Methods	Identical	N/A	Identical

| Performance
Standards: | The DT controlled phototherapy equipment performance data is the same as or very
similar to that of the claimed predicate devices. The ultraviolet lamps and cabinet
construction used in the production of the predicate device and the DT controlled
phototherapy equipment are the same. The only difference between the predicate
devices and the DT devices is the substitution of the DT controller for actual entry of
treatment. The rest of the devices (materials, construction, treatment modality, patient
safety, etc.) remains exactly the same. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | On the basis of the information provided in this Summary, the Daavlin Distributing
Company believes the DT controlled phototherapy equipment is substantially
equivalent to the legally commercialized predicate devices. |