K Number

Device Name

M Series Phototherapy Equipment

Manufacturer

Daavlin Distributing Co.

Date Cleared

2021-06-22

(89 days)

Product Code

FTC

Regulation Number

878.4630

Intended Use

The M Series Phototherapy Devices are indicated for use to treat diagnosed skin disorders such, as but not limited to, psoriasis, vitiligo, and atopic dermatiis (eczema) under the direction of a physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment, as well as the treatment environment. The population may range from pediatric, when accompanied by a responsible adult to operate it, to geriatric.

Device Description

The M Series Phototherapy Devices are intended to be used as a partial body therapeutic device. They are designed to be used under the direction of a physician for individuals who require phototherapy. Treatments are controlled through the ClearLink Software interface or the Smart Touch Software interface. Access to the interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules or millijoules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.

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

K182215, K100378

Reference Devices

K182215, K100378

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a phototherapy device with software interfaces for controlling treatment parameters based on physician-established protocols. There is no mention of AI or ML in the device description, intended use, or performance studies. The software appears to be for controlling pre-defined treatments, not for learning or adapting based on data.

Therapeutic

Yes
The device description explicitly states, "The M Series Phototherapy Devices are intended to be used as a partial body therapeutic device." It also treats diagnosed skin disorders, which is a therapeutic function.

Diagnostic

The device is described as a "therapeutic device" used to treat diagnosed skin disorders, not to diagnose them. It provides treatment based on physician direction and established protocols.

SaMD (Software as a Medical Device)

The device description explicitly states "The M Series Phototherapy Devices are intended to be used as a partial body therapeutic device" and mentions "The lamps and construction used in the production of the predicate devices and the M Series phototherapy equipment are the same," indicating a hardware component for delivering phototherapy. While software interfaces are mentioned for control, the core therapeutic function is hardware-based.

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. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
Device Description: The device is described as a partial body therapeutic device used for treatment.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The device delivers light therapy based on a physician's diagnosis and treatment plan.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The M 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 physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment, as well as the treatment environment. The population may range from pediatric, when accompanied by a responsible adult to operate it, to geriatric.

Product codes

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

The population may range from pediatric, when accompanied by a responsible adult to operate it, 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)

The M Series phototherapy equipment performance data is the same as or very similar to that of the claimed predicate device. The lamps and construction used in the production of the predicate devices and the M Series phototherapy equipment are the same. The only difference between the predicate devices and the M Series devices is the updated indication for use and intended use. The rest of the devices (materials, construction, treatment modality, patient safety, etc., remains exactly the same or similar.

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

Not Found

Predicate Device(s)

K182215, K100378

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 22, 2021

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

Re: K210881

Trade/Device Name: M Series Phototherapy Equipment Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: March 22, 2021 Received: March 25, 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.

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

Indications for Use

510(k) Number (if known)

K210881

Device Name

M Series 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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K210881 510(K) Summary:

Date of Summary:	March 22, 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 43506
Phone: (419) 636-6304 Ext. 207
Fax: (419) 636-1739
Email: mthiel@daavlin.com
Trade Name:	M Series Phototherapy Equipment
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 Controlled Phototherapy Equipment & 1 Series
Phototherapy Unit
510(k) Numbers:	K182215 & K100378
Product Code:	FTC
Company:	Daavlin Distributing Company
Device Description:	The M Series Phototherapy Devices are intended to be used as a
partial body therapeutic device. They are designed to be used
under the direction of a physician for individuals who require
phototherapy.
Treatments are controlled through the ClearLink Software
interface or the Smart Touch Software interface. Access to the
interface and stored information is restricted to individuals who
have been established by the physician as authorized operators.
Authorized operators program treatments in joules or millijoules
based on established treatment protocols governed by the
patient's skin type, condition, minimum erythemal dose (M.E.D.),
and treatment frequency.
Indications for Use:	The M 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 physician will determine the light spectrum
(ultraviolet to visible), the energy or duration of the treatment, as
well as the treatment environment. The population may range
from pediatric, when accompanied by a responsible adult to
operate it, to geriatric.
Intended Use:	The M Series Phototherapy Devices are intended to be used as a
partial body therapeutic device. They are designed to be used
under the direction of a physician for individuals who require
phototherapy.
Predicate Comparison:	The M Series phototherapy equipment is constructed in the same
design configuration as the predicate devices, utilizing identical
energy sources and materials of identical or similar composition.
The spectral output, mode of operation, labeling, treatment area,
treatment modality, patient safety, and general operating
principals of the M Series phototherapy equipment are the same
or similar to those of the predicate devices. The only difference
between the predicate devices and the M Series phototherapy
device is the updated indication for use and intended use.

	Subject Device	Predicate Device	Predicate Device
Features	M Series
Phototherapy
Equipment	1 Series Phototherapy
Unit	ClearLink
Phototherapy
Equipment
510(k)
Number	This Submission	K100378	K182215
Indications for
Use	The M 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
physician will
determine the light
spectrum (ultraviolet to
visible), the energy or
duration of the
treatment, as well as the
treatment environment.
The population may
range from pediatric,
when accompanied by a
responsible adult to
operate it, to geriatric.	The 1 Series Unit is a
therapeutic product
designed for
individuals who require
ultraviolet radiation for
diagnosed skin
disorders. The 1 Series,
equipped with PL-
L36W/03 Blue lamps,
is indicated for the
treatment of mild to
moderate acne vulgaris.	The ClearLink
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.
When equipped with
blue lamps the
ClearLink Controlled
Phototherapy
Equipment is intended
for use for the
treatment of mild to
moderate acne vulgaris.
Prescriptive	Yes	Yes	Yes
Patient
Population	Pediatric to Geriatric	Dermatology Patients	Pediatric to Geriatric
Patient
Contact	Patient comes in direct
contact with the acrylic
when placing hands or
feet inside for
treatment.	There is no direct
patient contact required
during treatment, but if
prescribed patient can
place hands directly on
the acrylic.	There is no direct
patient contact with the
device during treatment
– Areas of skin are
exposed to controlled
ultraviolet and blue
lamp radiation from a
distance of
approximately 9 inches
(22.86 cm) away.
Anatomical
Sites	Topical skin treatment	Topical skin treatment	Topical skin treatment
	Subject Device	Predicate Device	Predicate Device
Features	M Series
Phototherapy
Equipment	1 Series Phototherapy
Unit	ClearLink
Phototherapy
Equipment
510(k)
Number	This Submission	K100378	K182215
Application
Environment	Hospital, Clinic,
Medical Center, Private
Medical Practice, or
other environment
under the direction of a
physician.	Medical Office or
under direction of
physician	Hospital, Clinic,
Medical Center, Private
Medical Practice, or
Other Professional
Medical Environments
under direction of
physician
Materials	Assembled components
housed in metal frame
with reflective internal
surfaces and fluorescent
lamps	Assembled components
housed in plastic case	Assembled components
housed in metal frame
with reflective internal
surfaces and
fluorescent lamps
Manufacturing
Methods	Identical	Identical	Identical

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