(188 days)
REVIAN RED K173729
Not Found
No
The device description and performance studies focus on photobiomodulation and electrical/safety testing, with no mention of AI or ML components or data processing.
Yes
The device is indicated to treat Androgenetic Alopecia and promote hair growth, which are medical conditions that affect the body's structure and function.
No
The device is indicated to treat androgenetic alopecia and promote hair growth, which are therapeutic functions, rather than diagnosing a condition.
No
The device description explicitly states it is a "non-invasive, helmet-style photobiomodulation device" comprised of hardware components like a "wearable soft textile Cap using driver electronics, a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board containing 126 LEDs." This clearly indicates it is a hardware device, not software-only.
Based on the provided information, the Robin's Egg device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat Androgenetic Alopecia and promote hair growth. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is described as a "non-invasive, helmet-style photobiomodulation device" that uses light therapy. This is a physical treatment method, not a method for analyzing biological samples.
- Anatomical Site: The device is applied to the "scalp area," which is an external part of the body, not a biological sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic markers, or any process related to determining the presence or state of a disease or condition through in vitro examination.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Robin's Egg device does not fit this description. It is a therapeutic device.
N/A
Intended Use / Indications for Use
The Robin's Egg is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-I to I-4, II-I, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
Product codes (comma separated list FDA assigned to the subject device)
OAP
Device Description
The Telebrands' Robin's Egg is a non-invasive, helmet-style photobiomodulation device indicated to treat androgenetic alopecia in both men and women. It is operated using a single button at the front of the helmet to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment. The Robin's Egg is a system comprised of a wearable soft textile Cap using driver electronics, a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board containing 126 LEDs, as compared to 119 within the predicate device REVIAN RED. The Robin's Egg is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled by means of a single button and illuminated control display at the front of the helmet. Emitting red light energy within the 625 - 660 nm at 2.376 mW/cm² for a treatment time of 10 minutes, the Robin's Egg provides a well-established photobiomodulation effect upon the scalp to stimulate hair growth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C), home-based device
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)
No clinical trial data for the Robin's Egg was submitted for this 510(k). Non-clinical performance testing to demonstrate substantial equivalence to the predicate device included evaluation to current versions of IEC 60601-1 (Edition 3.2 2020-08) and 60601-1-2:2014 to confirm the device's electrical safety and electromagnetic compatibility, and conformance with ANSI/AAMI 60601-1-11:2015, IEC 60601-2-57 (Edition 1.0), and IEC 62471 (Edition 1.0). Biocompatibility testing of the Cap per ISO 10993-1:2018 confirmed no effects of the applied parts with particular attention to cytotoxicity, skin irritation or skin sensitization.
In addition, performance verification and validation testing demonstrate that the Robin's Egg meets user needs and design inputs and met requirements for its intended use and spectral and irradiance parameters of the subject are equivalent to the similar parameters of the predicate device.
Human factors evaluation of the Robin's Egg was performed following the current versions of ANSI/AAMI/IEC 62366-1:2015 and 60601-1-6 (Edition 3.2 2020-07) standards. The study protocol was designed to evaluate representative users of the device under expected conditions during simulated and actual use of the device. The Human Factors Engineering and Usability Engineering process involved several methodologies, including observational user research, formative and summative user testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
REVIAN RED K173729
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
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo 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.
September 17, 2024
Telebrands Corporation Shepard Bentley Regulatory Affairs Consultant One Telebrands Plaza Fairfield. New Jersey 07004
Re: K240689
Trade/Device Name: Robin's Egg Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: August 16, 2024 Received: August 16, 2024
Dear Shepard Bentley:
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.
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"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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 OS 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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
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,
Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE -S Date: 2024.09.17
15:39:24 -04'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & Infection Control Devices, Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240689
Device Name Robin's Egg
Indications for Use (Describe)
The Robin's Egg is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-I to I-4, II-I, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) |
|_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image is the logo for TeleBrands. The word "TELE" is in white letters inside of a red box with rounded corners. The word "Brands" is in blue letters and is partially behind the red box.
Image /page/4/Picture/1 description: The image contains two distinct elements: a logo and a text phrase. The logo features a yellow silhouette of a head with a lightbulb above it, set against a black background, with the word "BulbHead" written below. To the right of the logo, the text "Robin's Egg" is displayed in a bold, serif typeface, creating a contrast with the logo's modern design.
510(k) Summary # K240689
This summary of 510(k) safety and effectiveness information in being submitted in accordance with the requirements of SMDA and 21 CFR §890.5500.
1.1 Submitter Information:
| Sponsor: | Telebrands Corporation
One Telebrands Plaza,
Fairfield, NJ 07004 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Shepard G. Bentley, RAC
Regulatory Affairs Consultant
Phone: (949) 374 – 9187
Email: sbentley@bentleybiomed.com |
| Preparation Date: | 16 September 2024 |
1.2 Subject Device Information
| Trade/Proprietary Name: | Robin's Egg |
|---|---|
| Regulations Name: | Infrared Lamp per 21 CFR §890.5500 |
| Product Code: | OAP (laser, comb, hair) |
| Regulation Number: | 21 CFR §890.5500 |
| Regulatory Class: | Class 2 |
1.3 Predicate Device Information
Predicate Device: REVIAN RED K173729 PhotonMD, Inc.
1.4 Device Description
The Telebrands' Robin's Egg is a non-invasive, helmet-style photobiomodulation device indicated to treat androgenetic alopecia in both men and women. It is operated using a single button at the front of the helmet to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment. The Robin's Egg is a system comprised of a wearable soft textile Cap using driver electronics, a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board containing 126 LEDs, as compared to 119 within the predicate device REVIAN RED. The Robin's Egg is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user
5
Image /page/5/Picture/0 description: The image shows the logo for TeleBrands. The word "TELE" is in white letters inside a red rectangle with rounded corners. The word "Brands" is in blue letters and is partially overlapping the red rectangle. There is a registered trademark symbol in the lower right corner of the word "Brands".
Image /page/5/Picture/1 description: The image shows the logo for Robin's Egg. The logo includes a yellow image of a head with a lightbulb on top, and the word "BulbHead" written below. To the right of the logo, the words "Robin's Egg" are written in a large, bold font.
and is controlled by means of a single button and illuminated control display at the front of the helmet. Emitting red light energy within the 625 - 660 nm at 2.376 mW/cm² for a treatment time of 10 minutes, the Robin's Egg provides a well-established photobiomodulation effect upon the scalp to stimulate hair growth.
1.5 Indications for Use
The Robin's Egg device is indicated to treat Androgenetic Alopecia and to Promote Hair Growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and Promote Hair Growth in females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
1.6 Performance Test Summary
No clinical trial data for the Robin's Egg was submitted for this 510(k). Non-clinical performance testing to demonstrate substantial equivalence to the predicate device included evaluation to current versions of IEC 60601-1 (Edition 3.2 2020-08) and 60601-1-2:2014 to confirm the device's electrical safety and electromagnetic compatibility, and conformance with ANSI/AAMI 60601-1-11:2015, IEC 60601-2-57 (Edition 1.0), and IEC 62471 (Edition 1.0). Biocompatibility testing of the Cap per ISO 10993-1:2018 confirmed no effects of the applied parts with particular attention to cytotoxicity, skin irritation or skin sensitization.
In addition, performance verification and validation testing demonstrate that the Robin's Egg meets user needs and design inputs and met requirements for its intended use and spectral and irradiance parameters of the subject are equivalent to the similar parameters of the predicate device.
Studies Related to Human Factors Evaluation
Human factors evaluation of the Robin's Egg was performed following the current versions of ANSI/AAMI/IEC 62366-1:2015 and 60601-1-6 (Edition 3.2 2020-07) standards. The study protocol was designed to evaluate representative users of the device under expected conditions during simulated and actual use of the device. The Human Factors Engineering and Usability Engineering process involved several methodologies, including observational user research, formative and summative user testing.
1.7 Comparison to Predicate Device
Robin's Egg has similar technological characteristics as the REVIAN RED (K173729). including wavelength, light energy delivery method, timers and intended use.
| Table 1 - Summary of Predicate Device Comparison | ||
|---|---|---|
| 10. Summer and many and the comments of the comments of the country of the country of the country of the county of the country of the county of the county of the county of th | Comments of the county of the first of the may of the may be any | |
|---|---|---|
| 510/12 | ||
| ران جي القرار الملوب المنتدى المنتدى المنتدى المنتدى المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل | K240689 | TT 1 HO HOO |
| 111/ JIL |
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Image /page/6/Picture/0 description: The image shows the logo for TeleBrands. The logo is split into two parts, with the first part being the word "TELE" in white letters on a red background. The second part of the logo is the word "Brands" in blue letters.
Image /page/6/Picture/1 description: The image shows the words "Robin's Egg" next to the BulbHead logo. The BulbHead logo is a yellow head with a lightbulb on top of it. The words "Robin's Egg" are in a bold, serif font.
| Device | Robin's Egg | REVIAN RED | ||
|---|---|---|---|---|
| Company | Telebrands Corp. | PhotonMD, Inc. | ||
| Product Code | OAP | OAP | ||
| Rx/OTC | OTC | OTC | ||
| Intended Use/Indications | ||||
| for Use | The Robin's Egg device is | |||
| indicated to treat | ||||
| Androgenetic Alopecia and | ||||
| to Promote Hair Growth in | ||||
| males who have Norwood-Hamilton Classifications of | ||||
| IIa - V patterns of hair loss | ||||
| and to treat Androgenetic | ||||
| Alopecia and Promote Hair | ||||
| Growth in females who | ||||
| have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal | ||||
| patterns of hair loss; both | ||||
| with Fitzpatrick Skin Types | ||||
| I-IV. | The Robin's Egg device is | |||
| indicated to treat | ||||
| Androgenetic Alopecia and | ||||
| to Promote Hair Growth in | ||||
| males who have Norwood-Hamilton Classifications of | ||||
| IIa - V patterns of hair loss | ||||
| and to treat Androgenetic | ||||
| Alopecia and Promote Hair | ||||
| Growth in females who | ||||
| have Ludwig-Savin Scale | ||||
| I-1 to I-4, II -1, II-2 or | ||||
| frontal patterns of hair loss; | ||||
| both with Fitzpatrick Skin | ||||
| Types I - IV. | ||||
| Wearable Mounting | Textile Cap | Textile Cap | ||
| Wavelengths | 625 - 660 nm | 620 - 660 nm | ||
| Visible Light source | 126 Red LEDs | 119 Red LEDs | ||
| Battery | Lithium Polymer | Lithium Polymer | ||
| Treatment Time | Every day 10 minutes | Every day 10 minutes | ||
| Restrictions of Daily | ||||
| Irradiance | Yes, daily limit for | |||
| treatments | Yes, daily limit for | |||
| treatments |
1.8 Conclusion
This notification contains all information required by 21 CFR 807.87. Performance testing including electrical, electromagnetic compatibility, biocompatibility, software, and human factors demonstrates Robin's Egg meets the requirements for its intended use and does not raise any new types of safety or effectiveness questions when compared to the predicate device.
End 510(k) Summary