(114 days)
Not Found
No
The summary describes a light therapy device with different wavelengths and a mechanical arm, controlled by a touchscreen. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device's functionality. The performance studies focus on light output and uniformity, not algorithmic performance.
Yes
The device is described as "Rx Only mobile medical device" and its intended use is to "treat and document dermatological conditions," including specific conditions like "moderate inflammatory acne vulgaris," "superficial, benign vascular, and pigmented lesions," "temporary relief of minor muscle and joint pain, arthritis, and muscle spasm," and "treatment of periorbital wrinkles," all of which indicate a therapeutic purpose.
No
The "Intended Use / Indications for Use" section explicitly states, "FlashHeal does not diagnose the patient and does not come in contact with the patient at any point." The device's primary function, as described, is to emit energy for treatment, not for diagnosis.
No
The device description explicitly states that the device delivers LED therapies using various narrow-band wavelengths of light, and that the LEDs light source is placed inside an End-effector mounted on a mechanical arm. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- FlashHeal's Function: FlashHeal is a light therapy device that applies light directly to the patient's skin to treat dermatological conditions and provide temporary relief for pain. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for treating and documenting dermatological conditions and providing temporary relief for pain. It explicitly states it "does not diagnose the patient."
- Device Description: The description confirms it delivers LED therapies "without any direct patient contact" (referring to contact with internal tissues or fluids for diagnostic purposes).
Therefore, FlashHeal falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FlashHeal's use of blue, red, and infrared regions of the light spectrum is intended to emit energy to treat and document dermatological conditions.
i. The blue light (405 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
ii. The red light (625 nm wavelength) is generally indicated to treat superficial, benign vascular, and pigmented lesions.
iii. The infrared light (850 nm wavelength) is generally used for the temporary relief of minor muscle and joint pain, arthritis, and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
iv. The red and infrared lights combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
FlashHeal does not diagnose the patient and does not come in contact with the patient at any point.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
FlashHeal 2 (FlashHeal 2.0 model) is an Rx Only mobile medical device that delivers LED therapies for managing dermatological conditions using various narrow-band wavelengths of blue (405 nm), and infrared (850 nm) light without any direct patient contact. The LEDs light source is placed inside an End-effector mounted on a mechanical arm maneuvered by the healthcare professional. The system is operated by a touchscreen interface which allows the user to configure the treatment settings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance testing of FlashHeal was conducted to verify that the device met all design specifications. The test results demonstrate that FlashHeal complies with all requirements, including international and FDA-recognized consensus standards: -EN/IEC 60601-1 Ed. 3.2 en:2020-08 Medical electrical equipments for basic safety and essential performance
-EN/IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
-IEC/TR 60601-4-2 Ed. 1.0 en:2016 Medical Electrical Equipment - Part 4-2: Guidance And Interpretation - Electromagnetic Immunity: Performance Of Medical Electrical Equipment And Medical Electrical Systems
-IEC 60601-2-57:2011 Medical electrical equipment – Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
Additionally, software documentation and related procedures were submitted to an external reviewer, which declared compliance according to the IEC 62304:2006 + AMD1:2015 standard. Performance testing in relation to the above-mentioned standards has been carried out by a 3rd party testing lab.
Bench validation testing was performed with an irradiance sensor to gather relevant statistical information regarding FlashHeal 2.0's optical output and graphical information about the light distribution in the treatment area. The device maintains the desired irradiance across the enge, with deviations remaining below ±20%. Additionally, the effective irradiance does not exceed 186 mW/cm². The irradiance maps, standard deviations show a good uniformity of the optical output and within the project and software requirements. Therefore, FlashHeal 2.0 is as effective as the predicate devices as it can deliver the promised irradiance and in accordance with the reference device.
Clinical testing is not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bench validation testing: irradiance deviations below ±20%, effective irradiance does not exceed 186 mW/cm².
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.
K190938, K200659, K221083, K222751
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
January 18, 2024
InWound ApS Otto Ømann,Coo Søndervigvej 50 Copenhagen, 2720 Denmark
Re: K233077
Trade/Device Name: FlashHeal 2 (FlashHeal 2.0) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX, ILY Dated: December 22, 2023 Received: December 22, 2023
Dear Otto Ømann:
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.
1
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
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 approvals in the device master record (21 CFR 820.181).
Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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,
Tanisha L. Tanisha L. Hithe -S 2024.01.18 Hithe -S 14:42:47 -05'00'
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
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
FlashHeal 2 (FlashHeal 2.0)
Indications for Use (Describe)
FlashHeal's use of blue, red, and infrared regions of the light spectrum is intended to emit energy to treat and document dermatological conditions.
i. The blue light (405 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
ii. The red light (625 nm wavelength) is generally indicated to treat superficial, benign vascular, and pigmented lesions.
iii. The infrared light (850 nm wavelength) is generally used for the temporary relief of minor muscle and joint pain, arthritis, and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
iv. The red and infrared lights combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
FlashHeal does not diagnose the patient and does not come in contact with the patient at any point.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) #: K233077
510(k) Summary
Prepared on: 2024-01-12
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | InWound ApS | |||
|---|---|---|---|---|
| Applicant Address | Søndervigvej 50 Copenhagen 2720 Denmark | |||
| Applicant Contact Telephone | +45 53 77 74 54 | |||
| Applicant Contact | Mr. Otto Ømann | |||
| Applicant Contact Email | otto@inwound.com | |||
| Correspondent Name | InWound ApS | |||
| Correspondent Address | Søndervigvej 50 Copenhagen 2720 Denmark | |||
| Correspondent Contact Telephone | +45 53 77 74 54 | |||
| Correspondent Contact | Mr. Otto Ømann | |||
| Correspondent Contact Email | otto@inwound.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | FlashHeal 2 (FlashHeal 2.0) | |||
| Common Name | Laser surgical instrument for use in general and plastic surgery and in | |||
| dermatology | ||||
| Classification Name | Powered Laser Surgical Instrument | |||
| Regulation Number | 878.4810 | |||
| Product Code | GEX | |||
| Legally Marketed Predicate Devices | ||||
| 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K190938 | Phototherapy Systems | GEX | ||
| K200659 | Dermalux Tri-Wave MD | GEX | ||
| K221083 | Smartlux Mini | GEX | ||
| K222751 | LED Light Therapy Device, KN-7000L | GEX | ||
| Device Description Summary | ||||
| 21 CFR 807.92(a)(4) |
FlashHeal 2 (FlashHeal 2.0 model) is an Rx Only mobile medical device that delivers LED therapies for managing dermatological conditions using various narrow-band wavelengths of blue (405 nm), and infrared (850 nm) light without any direct patient contact.
5
The LEDs light source is placed inside an End-effector mounted on a mechanical arm maneuvered by the healthcare professional. The system is operated by a touchscreen interface which allows the user to configure the treatment settings.
Intended Use/Indications for Use
FlashHeal's use of blue, red, and infrared recirum is intended to emit energy to treat and document dermatological conditions.
i. The blue light (405 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
ii. The red light (625 nm wavelength) indicated to treat superficial, benign vascular, and pigmented lesions.
ii. The infrared light (850 nm wavelength) is generally used for the temporary relief of minor muscle and joint pain, arthritis, and muscle spasm; relieving stiffnes; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied. iv. The red and infrared lights combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
FlashHeal does not diagnose the patient and does not come in contact with the patient at any point.
Indications for Use Comparison
FlashHeal 2.0 device has the same indications for use as the predicate devices.
Technological Comparison
FlashHeal 2.0, despite exhibiting minor deviations in blue irradiance and treatment area, maintains to its predecessors. Any variance in manimal, affirming the device's safety. This does not alter the device's Risk Group level (2), ensuring compliance with established safety standards. The device also includes safety enhancements like skin temperature monitoring. InWound supplies safety goggles with the necessary Optical Densities (ODs) for eye protection. Bench validation testing has verfied that the differences between the devices in the targeted treatment area. It's important to note that FlashHeal 2.0 is not intended for treating large areas, which aligns with its safety and effectiveness profile.
Therefore, based on its design and manufacturing, FlashHeal 2.0 has been demonstrated to be very similar to the referenced predicate devices in terms of safety and effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Performance testing of FlashHeal was conducted to verify that the device met all design specifications. The test results demonstrate that FlashHeal complies with all requirements, including international and FDA-recognized consensus standards: -EN/IEC 60601-1 Ed. 3.2 en:2020-08 Medical electrical equipments for basic safety and essential performance
-EN/IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
-IEC/TR 60601-4-2 Ed. 1.0 en:2016 Medical Electrical Equipment - Part 4-2: Guidance And Interpretation - Electromagnetic Immunity: Performance Of Medical Electrical Equipment And Medical Electrical Systems
-IEC 60601-2-57:2011 Medical electrical equipment – Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
Additionally, software documentation and related procedures were submitted to an external reviewer, which declared compliance according to the IEC 62304:2006 + AMD1:2015 standard. Performance testing in relation to the above-mentioned standards has been carried out by a 3rd party testing lab.
Bench validation testing was performed with an irradiance sensor to gather relevant statistical information regarding FlashHeal 2.0's optical output and graphical information about the light distribution in the treatment area. The device maintains the desired irradiance across the enge, with deviations remaining below ±20%. Additionally, the effective irradiance does not exceed 186 mW/cm². The irradiance maps, standard deviations show a good uniformity of the optical output and within the project and software requirements. Therefore, FlashHeal 2.0 is as effective as the predicate devices as it can deliver the promised irradiance and in accordance with the reference device.
Clinical testing is not applicable.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)