(56 days)
No
The device description and lack of mention of AI/ML terms or performance studies related to algorithms indicate it is a simple LED light therapy device with a timer.
Yes
The device is indicated to "treat Androgenetic Alopecia and promote hair growth," which are therapeutic purposes.
No
The device description and intended use clearly state that it is for treatment (promoting hair growth and treating alopecia), not for diagnosing conditions.
No
The device description clearly states it is a "comb-shaped device that emits led light" and includes physical components like a main unit, charging dock, power cable, and a built-in battery. This indicates it is a hardware device, not software-only.
Based on the provided information, the Aduro Comb (Model: SZ-22A) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Aduro Comb Function: The Aduro Comb is a device that emits LED light directly onto the scalp to promote hair growth. It does not involve the analysis of any biological samples taken from the body.
- Intended Use: The intended use is to treat hair loss and promote hair growth, which is a direct therapeutic application, not a diagnostic test.
- Device Description: The description focuses on the physical characteristics of the device and its light emission, not on any components or processes related to sample analysis.
Therefore, the Aduro Comb falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Aduro Comb (Model: SZ-22A) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to I-4, II-1, 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 Aduro Comb is (Model: SZ-22A) a comb-shaped device that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 650nm (±10nm) while the comb teeth simultaneously part the user's hair to ensure the user's scalp. The device is designed as a handheld product, and it consists of the main unit, the charging dock and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.
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
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)
Non-Clinical Tests Performed:
- Electrical safety, and electromagnetic compatibility tests were performed to validate design and assure conformance with AAMI/ANSI ES60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-1-2, IEC 62471, and IEC 62133-2.
- Biocompatibility testing: The component materials are identical to previously cleared devices (K203271 and K202390) in formulation, processing, sterilization, and geometry. Compliance with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), and ISO 10993-10 (Irritation) is based on this information.
- Software verification and validation testing: Conducted and documented as recommended by IEC 62304 and FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software deemed "moderate" level concern.
Clinical Performance: Clinical testing was not needed. Non-clinical performance testing is considered sufficient to support safe and effective use.
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.
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.
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.
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 28, 2023
Light Tree Ventures Europe B.V. Alain Dijkstra CEO Laan van Ypenburg 108, 2497 GC Hague, Netherlands
Re: K230597
Trade/Device Name: Aduro Comb (Model SZ-22A) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: March 2, 2023 Received: March 3, 2023
Dear Alain Dijkstra:
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
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Indications for Use
510(k) Number (if known) K230597
Device Name Aduro Comb (Model: SZ-22A)
Indications for Use (Describe)
The Aduro Comb (Model: SZ-22A) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to I-4, II-1, 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 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | X |
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510(k) Summary of K230579
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Sponsor Name: Light Tree Ventures Europe B.V. Establishment Registration Number: 3017422691 Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Contact Person (including title): Alain Dijkstra (Manager) Tel: +86-135-10378748 Fax: +86-755-25024651 E-mail: regulation@kaiyanmedical.com
Application Correspondent
Contact Person: Alain Dijkstra Company: Light Tree Ventures Europe B.V. Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Tel: +86 755 82129361 Fax: +86 755 25024651 Email: requlation@kaiyanmedical.com
Manufacture
Company Name: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China
Summary Prepared Date: 2023-04-03
2. Subject Device Information
Trade Name: Aduro Comb, model: SZ-22A Classification Name: Laser, Comb, Hair (OAP) Review Panel: Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II
3. Predicate Device Information
Predicate Device (K211038) Sponsor: Biophotas Inc Trade Name: Biophotas Celluma RESTORE Classification Name: Laser, Comb, Hair 510(k) Number: K211038 Review Panel: General & Plastic Surgery Product Code: OAP
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Regulation Number: 21 CFR 890.5500 Regulation Class: II
4. Device Description
The Aduro Comb is (Model: SZ-22A) a comb-shaped device that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 650nm (±10nm) while the comb teeth simultaneously part the user's hair to ensure the user's scalp. The device is designed as a handheld product, and it consists of the main unit, the charging dock and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.
5. Intended Use / Indications for Use
The Aduro Comb (Model: SZ-22A) 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-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
6. Comparison to Predicate Device
Compared with the predicate device, the subject device has similar in the design principle, the intended use, the indications for use, functions and applicable standards. The differences between the subject device and the predicate device do not raise any new questions of safety or effectiveness.
| Elements of Comparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Company | Light Tree Ventures Europe | ||
| B.V. | Biophotas Inc | -- | |
| Trade Name | Aduro Comb (Model: SZ-22A) | Biophotas Celluma | |
| RESTORE | -- | ||
| Classification Name | Laser, Comb, Hair (OAP) | Laser, Comb, Hair (OAP) | -- |
| 510(k) Number | K230579 | K211038 | -- |
| Product Code | OAP | OAP | Same |
| Intended Use / Indications | |||
| for Use | The Aduro Comb (Model: SZ-22A) is indicated to treat | ||
| Androgenetic Alopecia and | |||
| promote hair growth in males | |||
| who have Norwood- Hamilton | |||
| Classifications of Ila - 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 | The BioPhotas | ||
| Celluma RESTORE is | |||
| indicated to treat | |||
| Androgenetic Alopecia | |||
| and promote hair | |||
| growth in males who | |||
| have Norwood- | |||
| Hamilton | |||
| Classifications of Ila - | |||
| V patterns of hair loss | |||
| and to treat | |||
| Androgenetic Alopecia | |||
| and promote hair | Same | ||
| Elements of Comparison | Subject Device | Predicate Device | Remark |
| Types I - IV. | 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. | ||
| Wavelengths | 650±10nm | 640nm (±25nm) | Similar |
| Note 1 | |||
| Treatment time | Each Treatment: 30 min | ||
| Total Treatment: every other day, for 16 weeks | Each Treatment:30 min Total Treatment: every other day, for 16 weeks | Same | |
| Treatment area | 31.5 cm² | 475 cm² | Different |
| Note 2 | |||
| Energy density (mw/cm²) | 2.77 mw/cm² | 2.77 mw/ cm² | Same |
| Treatment Dose(J/cm²) | 4.98 J/ cm² | 4.98 J/ cm² | Same |
| Energy Source | Light emitting diodes | Light emitting diodes | Same |
| Number of LEDs | 22 LEDs | No publicly available | Different |
| Note 2 | |||
| Power supply | Input: 100-240V~, 50/60Hz, 0.35Amax | ||
| Output:5V, 2A | |||
| Battery: DC 3.7 V, 600 mAh, 2.22 Wh | 110-120V | Similar | |
| Note 3 | |||
| Location for Use | OTC | OTC | Same |
| Safety and EMC | IEC 60601-1 | ||
| IEC 60601-1-11 | |||
| IEC 62471 | |||
| IEC 60601-2-57 | |||
| IEC 60601-1-2 | |||
| IEC 62133-2 | IEC 60601-1 | ||
| IEC 60601-1-2 | Similar | ||
| Note 4 | |||
| Biocompatibility | All patient contacting materials comply with ISO 10993-5, ISO 10993-10 | All patient contacting materials comply with ISO 10993-5, ISO 10993-10 | Same |
5
Note 1: Although the "Wavelength" of the subject device has a slight difference from the predicate devices, the wavelength of the subject device is within the error range of the predicate devices, so the wavelength of the subject device can be fully covered by the predicate devices. Therefore, this difference between the subject device and predicate devices will not raise any safety or effectiveness issues.
6
Note 2: Although the "Treatment area" and the "Number of LEDs" are different from the predicate devices because of the different design shapes, both the subject device and predicate devices have the same treatment parameters. Therefore, these slight differences between the subject device and predicate devices will not raise any safety or effectiveness issues.
Note 3: Although the "Power supply" of the subject device is not exactly the same as the predicate devices, both the subject device and the predicate devices conduct the safety test according to the IEC 60601 series standards, and the test results are in compliance with safety standards' requirements. So, this difference between the subject device and the predicate devices will not raise any safety or effectiveness issues.
Note 4: Although the description in "Safety and EMC" of the subject device is slightly different from the predicate devices, both the subject device and the predicate devices conducted the electrical safety and electromagnetic compatibility tests according to the international series standards, and the test results are in compliance with the standards' requirements. So, this difference between the subject device and the predicate devices will not raise any safety or effectiveness issues.
7. Test Summary
7.1 Non-Clinical Tests Performed
1) Electrical safety, and electromagnetic compatibility
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
- AAMI/ANSI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety � and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)
-
- IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- � IEC 60601-2-57 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
- ◆ IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- � IEC 62471 Photobiological safety of lamps and lamp systems
- � IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
2) Biocompatibility
The component materials of the subject device are identical to the corresponding component materials of the e previously cleared devices (K203271 and K202390) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents).
7
There is no change in biocompatibility since the previously cleared devices. Therefore, based on this information, the subject device can comply with the biocompatibility requirements of ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), and ISO 10993-10 (Irritation).
3) Software verification and validation testing
Software verification and validation testing were conducted and documentation was provided as recommended by the IEC 62304 and FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
7.2 Summary of Clinical Performance
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
Final Conclusion:
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K211038.