Who is the manufacturer of ClearLink Controlled Phototherapy Equipment?

Daavlin Distributing Company filed the 510(k) submission for ClearLink Controlled Phototherapy Equipment (K182215).

What is the FDA product code for ClearLink Controlled 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 ClearLink Controlled Phototherapy Equipment?

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

What are the predicate devices for ClearLink Controlled Phototherapy Equipment?

Flex Controlled Phototherapy Equipment (K050695); 1 Series (K100378).

Who can help prepare an FDA 510(k) submission like ClearLink Controlled 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.

ClearLink Controlled Phototherapy Equipment

K182215 · Daavlin Distributing Company · FTC · Oct 29, 2018 · General, Plastic Surgery

Device Facts

Record ID	K182215
Device Name	ClearLink Controlled Phototherapy Equipment
Applicant	Daavlin Distributing Company
Product Code	FTC · General, Plastic Surgery
Decision Date	Oct 29, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4630
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

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.

Device Story

Device delivers Narrow Band UVB, Broad Band UVB, or UVA light for dermatologic therapy; blue lamps used for acne. Operated by authorized personnel under physician direction in clinical settings (hospitals, private practices). System uses ClearLink software interface to manage treatment protocols; operators program doses in joules based on patient skin type, condition, minimum erythemal dose (M.E.D.), and frequency. Device consists of metal cabinet with reflective surfaces and fluorescent lamps; no direct patient contact occurs during treatment (patient positioned ~9 inches from source). Software controls ensure only authorized users access treatment parameters, enhancing safety by enforcing established protocols.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics, design, and intended use to legally marketed predicate devices.

Technological Characteristics

Metal frame construction with reflective internal surfaces; fluorescent UV/blue lamps. Energy source: UV radiation. Form factor: Cabinet-based phototherapy unit. Connectivity: Software-controlled interface for dose management. Sterilization: Not applicable (non-contact device). Software: Proprietary ClearLink interface for protocol management.

Indications for Use

Indicated for individuals (pediatric to geriatric) requiring ultraviolet radiation for diagnosed skin disorders; also indicated for treatment of mild to moderate acne vulgaris when equipped with blue lamps.

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

Flex Controlled Phototherapy Equipment (K050695)
1 Series (K100378)

Related Devices

K210881 — M Series Phototherapy Equipment · Daavlin Distributing Co. · Jun 22, 2021
K151795 — ML24000 UVA-1 Phototherapy Cabinet · Daavlin Distributing Co. · Sep 10, 2015
K153749 — 3 Series Phototherapy Unit · Daavlin Distributing Company · Jun 30, 2016
K041994 — MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM · Curelight, Ltd. · Oct 6, 2004
K212510 — 7 Series Phototherapy Device · Daavlin Distributing Co. · Nov 4, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Daavlin Distributing Company Michele Thiel Management Representative 205 West Bement Street P.O. Box 626 Bryan, Ohio 43506 October 29, 2018 Re: K182215 Trade/Device Name: ClearLink Controlled Phototherapy Equipment Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp for Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: August 13, 2018 Received: August 15, 2018 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 mav, 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 avare 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Neil R Ogden -S 2018.10.29 09:04:00 -04'00' For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K182215 Device Name ClearLink Controlled Phototherapy Equipment Indications for Use (Describe) 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. | 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) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ ## E. 510(K) Summary: | Date of Summary: | October 26, 2018 | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Submitter: | Daavlin Distributing Company | | Contact Person: | Michele Thiel 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: | ClearLink Controlled Phototherapy Equipment | | 510(K) Number: | K182215 | | Common Name | Ultraviolet 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: | Flex Controlled Phototherapy Equipment & 1 Series | | 510(k) Numbers: | K050695 & K100378 | | Product Code: | FTC | | Company: | Daavlin Distributing Company | | Device Description: | 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. The ClearLink Phototherapy Equipment delivers treatment, with Narrow Band UVB, Broad Band UVB and/or UVA ultraviolet light. Treatments are controlled through the ClearLink Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules 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 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. | | Predicate Comparison: | The ClearLink controlled phototherapy equipment is constructed in the same design configuration as the predicate device, utilizing identical energy sources (UV lamps) and materials of identical composition. The ClearLink controlled devices vary from the predicate device, in that the control system hardware and software of the ClearLink control has been updated to utilize current technology. The intended use, general and specific indications for use, spectral output, mode of operation, labeling, treatment area, and general operating principals of the ClearLink controlled equipment are the same or similar to those of the predicate device. The only difference between the predicate flex devices and the link devices is the substitution of the link controller for the flex controller for actual entry of doses. The rest of the devices (materials, construction, treatment modality, patient safety, etc., remains exactly the same. | {4}------------------------------------------------ {5}------------------------------------------------ | Features | Subject Device | Predicate Device | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | ClearLink Phototherapy Equipment | Flex Controlled Phototherapy Equipment | | 510(k) Number | This Submission | K050695 & K100378 | | Indications for Use | 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. | The Flex Controlled Phototherapy Equipment are ultraviolet emitting medical light sources, which are intended for use by or under the direction of a licensed physician for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I-VI). When equipped with blue lamps the Series-1 Phototherapy Equipment is intended for use for the treatment of mild to moderate acne vulgaris. | | Prescriptive | Yes | Yes | | Patient Population | Pediatric to Geriatric | Pediatric to Geriatric | | Patient Contact | 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. | There is no direct patient contact with the device during treatment - Areas of skin are exposed to controlled ultraviolet radiation from a distance of approximately 9 inches (22.86 cm) away. | | Anatomical Sites | Topical skin treatment | Topical skin treatment | | Application Environment | Hospital, Clinic, Medical Center, Private Medical Practice, or Other Professional Medical Environments 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 metal frame with reflective internal surfaces and fluorescent lamps | | Manufacturing Methods | Identical | Identical | {6}------------------------------------------------ | Performance Standards: | The ClearLink controlled phototherapy equipment performance data is the same as or very similar to that of the claimed predicate device. The ultraviolet light tubes and cabinet construction used in the production of the predicate device and the ClearLink controlled phototherapy equipment are the same. The only difference between the predicate flex devices and the link devices is the substitution of the link controller for the flex controller for actual entry of doses. The rest of the devices (materials, construction, treatment modality, patient safety, etc., remains exactly the same. | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| On the basis of the information provided in this Summary, the Daavlin Conclusion: Distributing Company believes the ClearLink controlled phototherapy equipment is substantially equivalent to the legally commercialized predicate device.