Who is the manufacturer of M Series Phototherapy Equipment?

Daavlin Distributing Co. filed the 510(k) submission for M Series Phototherapy Equipment (K210881).

What is the FDA product code for M Series Phototherapy Equipment?

FTC. It is classified under 21 CFR 878.4630 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for M Series Phototherapy Equipment?

510(k) clearance (submission type: Traditional).

What are the predicate devices for M Series Phototherapy Equipment?

ClearLink Controlled Phototherapy Equipment (K182215); 1 Series Phototherapy Unit (K100378).

Who can help prepare an FDA 510(k) submission like M Series Phototherapy Equipment?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

M Series Phototherapy Equipment

K210881 · Daavlin Distributing Co. · FTC · Jun 22, 2021 · General, Plastic Surgery

Device Facts

Record ID	K210881
Device Name	M Series Phototherapy Equipment
Applicant	Daavlin Distributing Co.
Product Code	FTC · General, Plastic Surgery
Decision Date	Jun 22, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4630
Device Class	Class 2
Attributes	Therapeutic, Pediatric

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.

Device Story

M Series Phototherapy Equipment is a partial body therapeutic device for dermatologic disorders. It utilizes fluorescent lamps to deliver ultraviolet or visible light to the skin. Authorized operators (physicians or supervised staff) program treatment protocols via ClearLink or Smart Touch software interfaces, specifying dosage in joules or millijoules based on patient skin type, condition, and minimum erythemal dose (M.E.D.). The device is used in hospitals, clinics, or medical practices. By delivering controlled light radiation, the device aims to treat skin conditions; the physician determines the spectrum, energy, duration, and environment. The system ensures safety through restricted access to treatment controls.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarity to predicate devices.

Technological Characteristics

Partial body phototherapy unit; metal frame construction with reflective internal surfaces; fluorescent lamp energy source; software-controlled interface (ClearLink/Smart Touch); prescription-use only.

Indications for Use

Indicated for treatment of diagnosed skin disorders including psoriasis, vitiligo, and atopic dermatitis (eczema) in patients ranging from pediatric (with adult supervision) to geriatric, under physician direction.

Regulatory Classification

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.

Predicate Devices

ClearLink Controlled Phototherapy Equipment (K182215)
1 Series Phototherapy Unit (K100378)

Related Devices

K182215 — ClearLink Controlled Phototherapy Equipment · Daavlin Distributing Company · Oct 29, 2018
K151795 — ML24000 UVA-1 Phototherapy Cabinet · Daavlin Distributing Co. · Sep 10, 2015
K230382 — 3 Series NeoLux · Daavlin Distributing Co. · Mar 24, 2023
K212510 — 7 Series Phototherapy Device · Daavlin Distributing Co. · Nov 4, 2021
K242908 — UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) · Shanghai Sigma High-Tech Co., Ltd. · Dec 19, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K210881 Device Name M Series Phototherapy Equipment #### Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-----------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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." {4}------------------------------------------------ # 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. | {5}------------------------------------------------ {6}------------------------------------------------ | | 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 | {7}------------------------------------------------ | 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. |