Who is the manufacturer of Enhanced AURORA Medical Diode System, and related accessories?

Psoria-Shield, Inc. filed the 510(k) submission for Enhanced AURORA Medical Diode System, and related accessories (K230076).

What is the FDA product code for Enhanced AURORA Medical Diode System, and related accessories?

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 Enhanced AURORA Medical Diode System, and related accessories?

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

Who can help prepare an FDA 510(k) submission like Enhanced AURORA Medical Diode System, and related accessories?

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.

Enhanced AURORA Medical Diode System, and related accessories

Q: What are the predicate devices for Enhanced AURORA Medical Diode System, and related accessories?

AURORA™ (K192411); PhotoMedex, Inc. XTRAC Ultra2 Excimer Laser System, Model AL10000 (K073659).

K230076 · Psoria-Shield, Inc. · FTC · Mar 8, 2023 · General, Plastic Surgery

Device Facts

Record ID	K230076
Device Name	Enhanced AURORA Medical Diode System, and related accessories
Applicant	Psoria-Shield, Inc.
Product Code	FTC · General, Plastic Surgery
Decision Date	Mar 8, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.

Device Story

Enhanced AURORA™ Medical Diode system provides targeted UVA or UVB phototherapy for dermatologic conditions. System comprises base station, touchscreen interface, and two wavelength-specific handpieces (UVA or UVB). Clinician selects treatment type; activates energy via handpiece trigger. Device delivers light to affected skin area; includes USB-connected thermal printer for treatment parameter verification. Used in clinical settings by healthcare providers. Benefits include targeted light delivery to specific skin lesions, minimizing exposure to healthy tissue. Software version 1.2.4 manages printer communication and treatment area display.

Clinical Evidence

Bench testing only. Verification confirmed UVA and UVB energy dosage output is within 10% of user-selected power settings using a Coherent PowerMax PC thermopile sensor array.

Technological Characteristics

Diode-based medical device; UVA (350-395nm) and UVB (300-320nm) light emission. Powered by 110V wall outlet. Features touchscreen, dual handpieces, and USB printer connectivity. Safety features include key lock and emergency stop button. Dimensions: 19" x 14" x 8"; Weight: 20 lbs. Software version 1.2.4.

Indications for Use

Indicated for patients with psoriasis, vitiligo, atopic dermatitis, eczema, seborrheic dermatitis, or leukoderma requiring targeted PUVA photochemistry or UVB phototherapy.

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

AURORA™ (K192411)
PhotoMedex, Inc. XTRAC Ultra2 Excimer Laser System, Model AL10000 (K073659)

Related Devices

K192411 — Psoria-Shield AURORA · Psoria-Shield · Jul 2, 2020
K022165 — THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2 · Theralight, Inc. · Jul 18, 2002
K072035 — RESOLVE UVB PHOTOTHERAPY SYSTEM · Allux Medical · Oct 16, 2007
K024020 — THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM · Theralight, Inc. · Jan 17, 2003
K021762 — BCLEAR · Lumenis, Inc. · Aug 23, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. March 8, 2023 Psoria-Shield, Inc. John Yorke General Manager 409 Mandeville St Utica, New York 13502 Re: K230076 Trade/Device Name: Enhanced AURORA™ system, and related accessories Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC, GEX Dated: January 9, 2023 Received: January 10, 2023 Dear John Yorke: 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 {1}------------------------------------------------ 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 (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 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 -S Jianting Wang Acting 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) K230076 Device Name Enhanced AURORA TM Medical Diode system, and related accessories Indications for Use (Describe) The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatius, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma. | 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}------------------------------------------------ #### 510(k) SUMMARY K230076 Psoria-Shield Inc's Enhanced AURORA™Medical Diode System, and related accessories The following information is provided as required by 21 C.F.R. § 807.87 (2003) for Psoria-Shield Inc's AURORA system Traditional 510(k) premarket notification: Document Control Clerk, Pursuant to 21 CFR 807.87, this is to notify you of the intention of Psoria-Shield, Inc. to introduce the Enhanced AURORA™ Medical Diode system and related accessories into commerce. ### GENERAL INFORMATION: | Premarket Application | | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Psoria-Shield, Inc. 409 Mandeville St Utica, NY 13502, USA Phone: 315 864 3465 Email: jy@psoriashield.com | | Contact: | John Yorke General Manager Psoria-Shield, Inc. 409 Mandeville St Utica, NY 13502, USA Phone: 315 864 3465 Email: jy@psoriashield.com | | Manufacturer: | Psoria-Shield, Inc. 409 Mandeville St Utica, NY 13502, USA Phone: 315 864 3465 Email: jy@psoriashield.com | | Date Prepared: | January 9, 2023 | | Classification Name: | Ultraviolet Lamp For Dermatologic Disorders Laser surgical instrument for use in general and plastic surgery and in dermatology | | CFR Citation Number: | 21 CFR 878.4630 21 CFR 878.4810 | | Product Code: | FTC, GEX | {4}------------------------------------------------ | Classification: | Class II | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Review Panel: | General & Plastic Surgery | | Trade Name: | Enhanced AURORA™ Medical Diode system and related accessories | | Common Name: | The Enhanced AURORA™ Medical Diode system and related accessories is a Diode medical device for dermatological disorders. | | Generic Name: | AURORA™ system, and related accessories | | Establishment Registration Number: | 3008872264 | | Predicate Devices: | The Psoria-Shield, Inc. AURORA™ (K192411 July 2, 2020) The PhotoMedex, Inc. XTRAC Ultra2 Excimer Laser System, Model AL10000 (K073659 January 2, 2008). | | Purpose of this Submission: | Psoria-Shield is seeking to introduce the Enhanced AURORA™ Medical Diode system and related accessories into commerce claiming substantial equivalence to the Psoria-Shield AURORA™ (K192411) and the PhotoMedex XTRAC Ultra2 Excimer Laser System, Model AL10000 (K073659). | | Indications for Use: | The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma. | | Device Description: | The Enhanced AURORA™ Medical Diode system and related accessories is designed to allow a clinician to easily apply UVA or UVB light to the patient's affected skin. The clinician selects the desired treatment type (UVA or UVB light) and applies the light through the appropriate handpiece by pointing the exit aperture towards the affected skin area. | | | The device is comprised of four main components: | | | - A base station - A touchscreen where the user can enter system commands - Two handpieces connected to the base by power cables. One - handpiece contains diode emitters that, when activated, emit UVA light. The other handpiece emits UVB light. Either handpiece will only operate if the appropriate wavelength is selected, so a user cannot | {5}------------------------------------------------ | - | accidentally activate the incorrect handpiece. Activation of energy occurs on depression of a trigger in the handpiece. A printer accessory that can print out verification of treatment parameters for hard copy records. The technical specifications for the AURORA are as follows: | | | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | | ● ● ● ● ● ● ● | Weight: Size: Min/Max power output (UVA): Min/Max power output (UVB): Power Increase Increments Size of beam: Dosage Accuracy: | 20 lbs 19" (W) x 14" (L) x 8" (H) 100 mJ/cm² / 3400 J/cm² 100 mJ/cm² / 3400 mJ/cm² 20mJ/100mJ 2.88 cm² 10% | | Technical Characteristics: | The Enhanced AURORA™ Medical Diode system and related accessories has the exact technological characteristics as the previously cleared AURORA™ (K192411 July 2,2020). Additionally, Psoria Shield is claiming substantial equivalence to the PhotoMedex XTRACT (K073659 January 2,2008). The Enhanced AURORA™ Medical Diode system and related accessories emits either UVA or UVB light, depending on which has been selected by the clinician. The power output is the same between UVA or UVB. The treatment area is the same between UVA or UVB. Treatment instructions are the same between both the UVA and UVB. Thus, the modified AURORA is the same device as the cleared AURORA™ (K192411 July 2,2020) except for the modifications listed in table below, and for which Psoria-Shield is seeking clearance: | | | | Modification | Detailed description of modification | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | A modification was implemented to improve the communication between the Enhanced AURORA and the thermal printer. Minor changes were made to the code of the Enhanced AURORA. These modified changes are incorporated in the new version of the code 1.2.4. | The update consisted of updating the USB Printer to improve the communication of the USB thermal printer address. The update was done to ensure that the firmware/software connection was fixed to allow the Enhanced AURORA™ Medical Diode system to properly function for the user. This was done to allow the clinician to utilize the thermal printer function while additionally preventing them from overriding the Patient ID function while utilizing the device. A software change to the code was made in order for the clinician to read results before printing and to include an added treatment area to the results screen on the Enhanced AURORA ™ Medical Diode system. | {6}------------------------------------------------ | Performance Data: | Psoria-Shield has performed bench testing consistent with design verification activities required under 21 CFR 820 to confirm the design modifications have no effect on the safety or effectiveness of the modified device. This was confirmed through verifying that UVA and UVB energy dosage output are within 10% of user-selected power settings. Testing was performed using a production-equivalent Enhanced AURORA™ Medical Diode system and related accessories, with energy dosage measured using a Coherent PowerMax PC thermopile sensor array. Testing was performed to confirm the joule output of the device in a cm² area in the center of both the thermopile and using the center of the chipset arrays for the most accurate reading possible. Screenshots of the AURORA device were taken at the same time to demonstrate the dosage that the device was calibrated to deliver in the pulse. | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substantial Equivalence: | The Enhanced AURORA™ Medical Diode system and related accessories has the exact same use as the previously cleared AURORA™ (K192411 July 2, 2020). In addition, the Enhanced AURORA™ Medical Diode system and related accessories has the exact indications and principles of operation as the predicate devices, the exact technological characteristics to the AURORA™ (K192411 July 2,2020) and very similar technical characteristics to the PhotoMedex XTRACT (K073659 January 2, 2008). Although there are minor differences between the Enhanced AURORA™ Medical Diode system and related accessories and its predicate devices. Note that the indications for use (IFU's) are not being changed, modified, or altered in any fashion from the predicate devices. Thus, the Enhanced AURORA™ Medical Diode system and related accessories is substantially equivalent to the predicate devices. | | Conclusion: | In summary, the company's Enhanced AURORA™ Medical Diode system and related accessories has the exact same use as the previously cleared AURORA™ (K192411 July 2,2020). In addition, the Enhanced AURORA™ Medical Diode system and related accessories has the exact indications and principles of operation as the predicate devices, and the exact technological characteristics to the AURORA™ (K192411 July 2,2020) and very similar technical characteristics to the PhotoMedex XTRACT (K073659 January 2, 2008). Although there are minor differences between the Enhanced AURORA™ Medical Diode system and related accessories and its predicate devices as summarized in table below. Note that the indications for use (IFU's) are not being changed, modified, or altered in any fashion from the predicate devices. Thus, the Enhanced | {7}------------------------------------------------ AURORA™ Medical Diode system and related accessories is substantially equivalent to the predicate devices. | | Psoria Shield Enhanced AURORA™ Medical Diode system and related accessories (K230076) | Psoria Shield AURORA™ (K192411) | PhotoMedex XTRAC Ultra² Excimer Laser System, Model AL10000 (K073659) | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The Enhanced AURORA™ and related accessories is intended to be used for the treatment of dermatologic disorders. | The AURORA is intended to be used for the treatment of dermatologic disorders. | The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma. | | Indications for Use | The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma. | The AURORA system is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma. | UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma. | | Wavelength | UVA:350-395nm UVB:300-320nm | UVA: 350-395nm UVB:320-320nm | 308nm | ## Substantial Equivalence Table Comparing Subject and Predicate Device {8}------------------------------------------------ | Maximum Fluence to Tissue: | Up to 3,400mJ/cm² | Up to 3,400mJ/cm² | 2-3.8 mJ/cm2 | |-------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | Pulse Duration: | C/W | C/W | Quasi continuous output | | Beam Delivery: | Flexible Fiber Optic and Therapeutic Handpieces | Flexible Fiber Optic and Therapeutic Handpieces | Flexible Fiber Optic and Therapeutic Handpieces | | Aiming Beam | YES | YES | YES | | Power Source | 110V wall power | 110V wall power | 110V wall power | | Dimensions | H: 19 | H:19 | H: 34 | | | D: 14 | D:14 | D: 39 | | | W: 8 | W: 8 | W:18 | | Safety Features | Key lock to prevent accidental energy emission and Emergency stop button | Key lock to prevent accidental energy emission and Emergency stop button | Key lock to prevent accidental energy emission and emergency stop button | | Weight | 20lbs | 20lbs | 220lbs | | Accessories | USB-connected printer | USB-connected printer | NA |