(57 days)
The Hair Growth System (Model: KN-8000B/KN-8000C/KN-8000E) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications Ila-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.
The Hair Growth System (Model: KN-8000B/KN-8000D/KN-8000E) is hands-free, portable, noninvasive, low-level laser device, which consists of red visible light diode lasers and/or LEDs, to produce red light operating at 650nm wavelength (maximum output power of each is 5mW). The laser sources are arranged in a dot matrix arrangement in the inner of the helmet, which could take into account of every hair follicle and promote rapid hair growth. The device will automatically pause therapy if the user's head is moved outside of the zone of radiation and will resume therapy when the correct head position is reestablished.
The device could be powered by internal rechargeable li-on battery (Rated 7.2Vd.c. 2100mAh), and it can also be supplied by specified external adapter with rated Input 100-240Vac. 50/60Hz and rated Output 9Vdc 3A.
For KN-8000D and KN-8000E, the device emits an audible voice prompt when the treatment is going to start/pause/end, and the device is going to shut down.
This document is a 510(k) premarket notification for a medical device called "Hair Growth System" (Models: KN-8000B/KN-8000C/KN-8000D/KN-8000E). It seeks to demonstrate substantial equivalence to previously cleared devices.
The information provided does not include details about specific acceptance criteria, reported device performance measurements, sample sizes, ground truth establishment, or clinical study designs in the way typically expected for a detailed AI device study. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with recognized standards.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and performance standards. The "performance" is implicitly demonstrated through adherence to these standards and similarity to already-cleared devices.
The tables provided (pages 6-7) are comparison tables showing technical characteristics of the subject device against predicate devices, with "Verdict" indicating if they are substantially equivalent (SE) or have minor differences. These are not performance metrics in the typical sense for AI, but rather technical specifications.
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "Clinical performance is not deemed necessary." (Page 10)
Therefore, there was no clinical test set with a specific sample size, nor information on data provenance for such a set. The submission focuses on non-clinical testing and substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no clinical test set was used, there were no experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a standalone hardware device (infrared lamp/laser for hair growth), not an AI-powered diagnostic or assistive tool that would involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to a standalone hardware device, not a software algorithm. Its "standalone performance" is assessed through compliance with electrical safety, EMC, biocompatibility, usability, and software verification standards. The comparison tables illustrate that its technical specifications (wavelength, output, number of diodes/LEDs) are within ranges or similar to those of its predicate devices, which have already been deemed safe and effective.
7. The Type of Ground Truth Used
Given that "Clinical performance is not deemed necessary," there was no "ground truth" in the sense of expert consensus, pathology, or outcomes data from a clinical trial for the subject device to evaluate its effectiveness. The ground truth for its safety and function is established by compliance with engineering and safety standards (e.g., IEC 60601-1, IEC 60825-1, ISO 10993) and the demonstrated substantial equivalence to predicate devices, which were presumably cleared based on their own safety and effectiveness data (either clinical or through substantial equivalence to even earlier devices).
8. The Sample Size for the Training Set
Not applicable. This is a hardware device submission, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Device Evaluation in the Document:
The "Hair Growth System" was evaluated through:
- Lab bench testing for:
- Electrical safety and performance (IEC 60601-1, IEC 60825-1, IEC 62471, IEC 60601-2-57)
- Electromagnetic compatibility (IEC 60601-1-2)
- Biocompatibility (ISO 10993-5, ISO 10993-10) for patient-contacting materials
- Usability (IEC 62366)
- Software verification and validation (FDA guidance for software in medical devices)
- Comparison to predicate devices (DermaScalp Laser Cap, Capillus devices, iRestore Hair Growth System, iRestore Professional 282) to establish substantial equivalence in terms of:
- Intended Use
- Device Type (LLLT)
- Prescription status (OTC)
- Waveform and Wavelength (655nm ±5nm, 655nm ±20nm for LED)
- Amounts of laser diodes/LEDs
- Laser radiation output (<5mW per diode/LED)
- Laser classification (Class 3R according to IEC 60825-1)
- Treatment parameters (time, frequency)
- Total laser irradiance
- Appearance design
- Safety and Performance Features (compliance with standards)
- Biocompatibility (compliance with ISO 10993 standards)
The conclusion is that the device is substantially equivalent to the predicate devices because its technological characteristics, features, specifications, materials, and intended use are similar, and the noted differences do not raise new issues of safety or effectiveness.
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June 3, 2020
Xuzhou Kernel Medical Equipment Co., Ltd. % Jet Li Regulation Manager Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, Guangdong China
Re: K200929
Trade/Device Name: Hair Growth System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: March 15, 2020 Received: April 7, 2020
Dear Jet Li:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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,
Colin Kejing Chen, Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200929
Device Name
Hair Growth System (Model: KN-8000B/KN-8000C/KN-8000D/KN-8000E)
Indications for Use (Describe)
The Hair Growth System (Model: KN-8000B/KN-8000C/KN-8000E) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications Ila-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Date of the summary prepared: May 30, 2020
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. This is a traditional 510(K) submission with no previous application.
1. Submitter's Information
Sponsor
- � Company Name: Xuzhou Kernel Medical Equipment Co., Ltd.
- Address: Kernel Mansion, Economic Development District, Xuzhou City, Jiangsu Province, � China
- � Phone: +86 1831 685 8036
- Fax: +86 0516-87732208 13776587162 �
- Contact Person (including title): Wang Jing (Management Representative) �
- E-mail: wikernel@126.com �
Application Correspondent:
- Company Name: Guangzhou KEDA Biological Tech Co., Ltd. �
- Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China �
- � Contact Person: Jet Li
- Tel: +86-18588874857 �
- Email: med-jl@foxmail.com �
Subject Device Information 2.
- � Trade Name: Hair Growth System
- Model: KN-8000B/KN-8000C/KN-8000D/KN-8000E �
| DataModel | LD Quantity | LED Quantity |
|---|---|---|
| KN-8000B | 204 | -- |
| KN-8000C | 80 | 30 |
| KN-8000D | 21 | 30 |
| KN-8000E | 81 | -- |
- Common Name: Lamp, non-heating, for promotion of hair growth �
- Classification name: Infrared lamp �
- � Review Panel: General & Plastic Surgery
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- Product Code: OAP (Laser, comb, hair) �
- � Requlation Class: 2
- Regulation Number: 21 CFR 890.5500 �
3. Predicate Device Information
- � Predicate Devices for KN-8000B and KN-8000E
| Predicate I | Predicate II | |
|---|---|---|
| Sponsor | DermaScalp LLC | Capillus LLC |
| Device Name | DermaScalp Laser Cap | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 |
| 510(k) Number | K173846 | K163170 |
| Product Code | OAP | OAP |
| Regulation Number | 21 CFR 890.5500 | 21 CFR 890.5500 |
| Regulation Class | 2 | 2 |
Predicate Devices for KN-8000C and KN-8000D �
| Predicate I | Predicate II | |
|---|---|---|
| Sponsor | Freedom Laser Therapy, Inc. | Freedom Laser Therapy, Inc. |
| Device Name | iRestore Hair Grow th System | iRestore Professional 282 |
| 510(k) Number | K151662 | K183417 |
| Product Code | OAP | OAP |
| Regulation Number | 21 CFR 890.5500 | 21 CFR 890.5500 |
| Regulation Class | 2 | 2 |
2. Device Description
The Hair Growth System (Model: KN-8000B/KN-8000D/KN-8000E) is hands-free, portable, noninvasive, low-level laser device, which consists of red visible light diode lasers and/or LEDs, to produce red light operating at 650nm wavelength (maximum output power of each is 5mW). The laser sources are arranged in a dot matrix arrangement in the inner of the helmet, which could take into account of every hair follicle and promote rapid hair growth. The device will automatically pause therapy if the user's head is moved outside of the zone of radiation and will resume therapy when the correct head position is reestablished.
The device could be powered by internal rechargeable li-on battery (Rated 7.2Vd.c. 2100mAh), and it can also be supplied by specified external adapter with rated Input 100-240Vac. 50/60Hz and rated Output 9Vdc 3A.
For KN-8000D and KN-8000E, the device emits an audible voice prompt when the treatment is going to start/pause/end, and the device is going to shut down.
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3. Intended Use / Indications for Use
The Hair Growth System (Model: KN-8000B/KN-8000C/KN-8000E) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications Ila-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.
4. Test Summary
The Hair Growth System has been evaluated for its safety and performance by lab bench testing as following:
- � Electrical safety and performance test according to IEC 60601-1, IEC 60825-1, IEC 62471 and IEC 60601-2-57 standard
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standard
- � Usability test according to IEC 62366
- � Software verification and validation test according to the requirements of the FDA "Guidance for Premarket Submissions and for Software Contained in Medical Devices"
5. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, and intended use of Hair Growth System, model: KN-8000B/KN-8000D/KN-8000E is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
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| Substantial Equivalence Comparison Table forKN-8000B/KN-8000E | |||||
|---|---|---|---|---|---|
| Elements of Comparison | Subject Device | Predicate Device I | Predicate Device II | Verdict | |
| 510(k) Number | TBD | K173846 | K163170 | -- | |
| Device Name | Hair Grow th SystemKN-8000B/ KN-8000E | DermaScalp Laser Cap | Capillus 82, Capillus 202, Capillus272 Pro, 272 Office Pro, Capillus302, Capillus 312, and Capillus 352 | -- | |
| Product Code | OAP | OAP | OAP | SE | |
| Regulation Number | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 | SE | |
| Regulation Class | 2 | 2 | 2 | SE | |
| LLLT Device Type | LLLT | LLLT | LLLT | SE | |
| Prescription | OTC | OTC | OTC | SE | |
| Intended Use | The Hair Grow th System (Model: KN-8000B/KN-8000C/KN-8000D/KN-8000E) isintended for the promotion of hair grow th infemales with androgenic alopecia w hohave Ludwig-Savin Classifications I-II, andin males with androgenetic alopecia w hohave Norwood Hamilton Classifications Ila-V; and both genders having FitzpatrickClassification of Skin Phototypes I-IV. | The family of DermaScalp Laser Capdevices are indicated to treatAndrogenetic Alpopecia and promotehair grow th in Males w ho haveNorw ood Hamilton Classifications ofIla to V patterns of hair loss and totreat Androgenetic Alopecia andpromote hair grow th in Females w hohave Ludwig (Savin) Scale I-1 to I-4,Il-1, Il-2, or frontal; both withFitzpatrick Skin Types I to IV. | The Capillus laser domes 82, 202, 272Pro, 272 OfficePro, 302, 312, and 352,are intended to treat AndrogeneticAlopecia and promote hair grow th inmales w ho have Norw ood -HamiltonClassifications of Ila to V patterns ofhair loss and to treat AndrogeneticAlopecia and promote hair grow th infemales who have Ludwig (Savin) ScaleI-1 to I-4, II-1, II-2, or frontal; both withFitzpatrick Skin Types I to IV. | SEMinordifference | |
| Waveform | Visible red laser | Visible red laser | Visible red laser | SE | |
| Wavelength | 655nm ±5nm | 650nm | 650nm | SENote 1 | |
| Amounts of laser diode | KN-8000B: 204KN-8000E: 81 | 50, 80, 120, 148, 180, 202, 224, 272 | 82, 202, 272, 302, 312, 352 | SENote 2 | |
| Laser radiation output | <5mW | <5mW | ≤5mW | SENote 1 | |
| Classification according toIEC60825-1 | Class 3R | Class 3R | Class 3R | SE | |
| Substantial Equivalence Comparison Table forKN-8000B/KN-8000E | |||||
| Elements of Comparison | Subject Device | Predicate Device I | Predicate Device II | Verdict | |
| Treatment | Each Treatment: 25-35min,Total Treatment: every other day | 17weeks, every other day (indefinite) | 17weeks, every other day (indefinite) | SENote 2 | |
| Total laser irradiance | KN-8000B: ≤1,020mWKN-8000E: ≤405mW | Diode 50: <250mW,Diode 80: <400mW,Diode 120: < 600mW,Diode 148: <740mW,Diode 180: <900mW,Diode 202: <1,010mW,Diode 224: <1,120mW,Diode 272: <1,360mW | Diode 82: <410mW,Diode 202: <1,010mW,Diode 272: <1,360mW,Diode 302: <1,510mW,Diode 312: <1,560mW,Diode 352: <1,760mW | SENote 2 | |
| Appearance Design | Helmet cap | Cap | Cap | SEMinordifference | |
| Safety and PerformanceFeature | Complied with IEC 60601-1, IEC 60601-1-2, IEC 60825-1 | Complied with IEC 60601-1, IEC60601-1-2, IEC 60825-1, IEC 60601-1-11 | Complied with IEC 60601-1, IEC60601-1-2, IEC 60825-1 | SENote 3 | |
| Biocompatibility | All patient contacting materials arecomplied with ISO 10993-5, ISO 10993-10 | All patient contacting materials arecomplied with ISO 10993-1, ISO10993-5 | All patient contacting materials arecomplied with ISO 10993-5, ISO 10993-10 | SENote 3 |
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| Substantial Equivalence Comparison Table forKN-8000C/KN-8000D | ||||
|---|---|---|---|---|
| Elements of Comparison | Subject Device | Predicate Device I | Predicate Device II | Verdict |
| 510(k) Number | TBD | K151662 | K183417 | -- |
| Device Name | Hair Grow th System | iRestore Hair Grow th System | iRestore Professional 282 | -- |
| Substantial Equivalence Comparison Table forKN-8000C/KN-8000D | ||||
| Elements of Comparison | Subject Device | Predicate Device I | Predicate Device II | Verdict |
| KN-8000C/ KN-8000D | ||||
| Product Code | OAP | OAP | OAP | SE |
| Regulation Number | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 | SE |
| Regulation Class | 2 | 2 | 2 | SE |
| LLLT Device Type | LLLT | LLLT | LLLT | SE |
| Prescription | OTC | OTC | OTC | SE |
| Intended Use | The Hair Growth System (Model: KN-8000B/KN-8000C/KN-8000D/KN-8000E) isintended for the promotion of hair growth infemales with androgenic alopecia who haveLudwig-Savin Classifications I-II, and inmales with androgenetic alopecia who haveNorwood Hamilton Classifications IIa-V; andboth genders having Fitzpatrick Classificationof Skin Phototypes I-IV. | The iRestore Hair Growth System isindicated to promote hair growth infemales with androgenetic alopeciawho have Ludwig-SavinClassifications of I - II, males whohave Norwood-HamiltonClassifications of IIa - V and for both,Fitzpatrick Classification of SkinPhototypes I to IV. | The iRestore Professional 282 isindicated to promote hair growth infemales with androgenetic alopeciawho have Ludwig-SavinClassifications of I-II, males who haveNorwood-Hamilton Classifications ofIIa-V and for both, FitzpatrickClassification of Skin Phototypes I toIV. | SE |
| Waveform | Visible red laser and light | Visible red laser and light | Visible red laser and light | SE |
| Wavelength | LD: 655nm±5nmLED: 655nm±20nm | 655nm | 650nm±10nm | SENote 1 |
| Amounts of LED | KN-8000C: 30KN-8000D: 30 | 30 | 200 | SENote 2 |
| Amounts of laser diode | KN-8000C: 80KN-8000D: 21 | 21 | 82 | SENote 2 |
| Classification according toIEC60825-1 | Class 3R | Class 3R | Class 3R | SE |
| Treatment time | Each Treatment: 25-35minTotal Treatment: every other day | Each Treatment: 25minTotal Treatment: every other day, onnon-consecutive days, for 16weeks | Each Treatment: 25minTotal Treatment: every other day, onnon-consecutive days, for 16weeks | SENote 2 |
| Appearance Design | Helmet cap | Helmet | Helmet | SE |
| Substantial Equivalence Comparison Table forKN-8000C/KN-8000D | ||||
| Elements of Comparison | Subject Device | Predicate Device I | Predicate Device II | Verdict |
| Safety and PerformanceFeature | Complied with IEC 60601-1, IEC 60601-1-2,IEC 60825-1, IEC 62471, IEC 60601-2-57 | Complied with IEC 60601-1, IEC60601-1-2, IEC 60825-1, IEC 60601-1-11 | Complied with IEC 60601-1, IEC60601-1-2, IEC 60825-1, IEC 60601-1-11 | SENote 3 |
| Biocompatibility | All patient contacting materials are compliedwith ISO 10993-5, ISO 10993-10 | All patient contacting materials arecomplied with ISO 10993-5, ISO10993-10 | All patient contacting materials arecomplied with ISO 10993-5, ISO10993-10 | SE |
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Comparison in Detail(s):
Note 1:
Although the Wavelength and Laser radiation output of subject device have a little difference to the predicate devices, these parameters are similar to the predicate devices, and these minor difference of wavelength will not affect the main function. So the differences will not raise any safety or effectiveness issue.
Note 2:
Although the Amounts of LED and/or laser diode/Treatment Time/Total Irradiance of subject device and predicate devices are a little difference, the energy and power parameters' range of subject device can be covered by predicate device's several models' range; they are very similar. So these parameters' differences will not raise any safety or effectiveness issue.
Note 3:
Although the accepted FDA recognized standards of subject device are a little different from the predicate devices, they all comply with IEC 60101-1/IEC 60601-1-2/IEC 60825, and the subject device also complies with IEC 62471 requirements, so these differences will not affect the critical functions or the normal use.
Summary for clinical test 6.
Clinical performance is not deemed necessary.
7. Conclusion
The subject device Hair Growth System (KN-8000B/KN-8000D/KN-8000E) has all features of the predicate devices for intended use. Thus, the subject device is substantially equivalent to the predicate devices.
§ 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.