The Hair Growth Comb (Model: SZ-23 ,SZ-23A,) 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 1-4, Il-1, Il-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

Device Description

The Hair Growth Comb is (Model: SZ-23, SZ-23A) 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 light reaches 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.

AI/ML Overview

This document is a 510(k) Summary for a medical device (Hair Growth Comb, Models SZ-23, SZ-23A). It provides information regarding the device's substantial equivalence to previously cleared predicate devices, primarily focusing on its technical characteristics and safety testing.

Crucially, this document states: "Clinical testing was not needed for this 510(k)." This means that the submission does not include a clinical study designed to prove the device meets specific performance criteria related to the effectiveness of promoting hair growth. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document in the context of device performance regarding its intended clinical effect.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical testing for safety and electrical/software compliance, not clinical efficacy.

However, I can provide information based on the other aspects of the document:

Based on the provided 510(k) Summary, the following information can be extracted:

1. A table of acceptance criteria and the reported device performance:

As no clinical efficacy study was conducted for this 510(k), there are no clinical performance acceptance criteria and reported device performance related to hair growth in this document. The "acceptance criteria" mentioned are related to safety and functional compliance.

Acceptance Criteria (Non-Clinical)	Reported Device Performance (as stated in document)
Electrical safety and electromagnetic compatibility:	Conforms to voluntary design standards: - ANSI/AAMI ES60601-1: 2005 & A1:2012 & A2:2021 - IEC 60601-1-11: 2015+AMD1:2020 - IEC 60601-2-57: 2023 - IEC 60601-1-2: 2014+AMD1:2020 - IEC 62471: 2006 - IEC 62133-2: 2017+AMD1:2021 - IEC 60601-1-6: 2010+AMD1:2013+AMD2:2020 - IEC 62366-1: 2015+AMD1:2020
Biocompatibility: (for PC+ABS shell, surface-skin contact, <24 hours duration) - Cytotoxicity (ISO 10993-5) - Sensitization (ISO 10993-10) - Irritation or intracutaneous reactivity (ISO 10993-10)	Complied with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization). "Hair Growth Comb (Model: SA-23, SA-23A) is biocompatible for its intended use."
Software verification and validation: (for "basic" level software, where failure could lead to minor injury)	Conducted and documentation provided as recommended by IEC 62304 and FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions."

2. Sample size used for the test set and the data provenance:

Clinical Test Set: Not applicable. "Clinical testing was not needed for this 510(k)." The testing described is non-clinical (electrical safety, EMC, biocompatibility, software).
Data Provenance for Non-Clinical Tests: Performed by the manufacturer (Shenzhen Nuon Medical Equipment Co., Ltd) or contracted labs, adhering to international standards. The document doesn't specify countries of origin for test data, but the manufacturer is based in China. This is a pre-market submission, so the testing would be conducted retrospectively to the submission date.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable for clinical ground truth related to hair growth efficacy, as no clinical study was conducted.
For non-clinical testing, the "ground truth" is established by compliance with international standards (e.g., ISO, IEC) and the expertise lies within the testing laboratories and their personnel. The document does not specify the number or qualifications of these experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for clinical efficacy. For non-clinical compliance testing, "adjudication" in the sense of expert consensus on ambiguous cases is not a relevant concept. Compliance is determined by meeting pre-defined test parameters outlined in the standards.

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 physical comb that emits LED light, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical therapeutic device, not an algorithm.

7. The type of ground truth used:

Clinical Ground Truth: Not applicable, as no clinical efficacy study was conducted for hair growth. The substantiation for efficacy relies on substantial equivalence to predicate devices which were presumably cleared based on prior clinical data or deemed effective through other means (historical data, published literature, etc.).
Non-Clinical Ground Truth: Established by adherence to recognized international standards for electrical safety (IEC 60601 series, IEC 62471), battery safety (IEC 62133-2), biocompatibility (ISO 10993 series), and software validation (IEC 62304, FDA Guidance).

8. The sample size for the training set:

Not applicable for clinical efficacy, as no clinical study was conducted. For non-clinical tests, "training set" is not a relevant concept.

9. How the ground truth for the training set was established:

Not applicable.

Summary

{0}------------------------------------------------

November 8, 2024

Image /page/0/Picture/1 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 acronym along with the full name of the agency on the right. The FDA acronym and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue. The logo is simple and professional, reflecting the agency's role in protecting public health.

Shenzhen Nuon Medical Equipment Co., Ltd Alain Dijkstra Regulatory Affairs Engineer 1F-3F, No.27-2, Xintang Rd, Xintian Comm, Fuhai Str, Baoan Dist Shenzhen, GuangDong 518000 China

Re: K241342

Trade/Device Name: Hair Growth Comb (SZ-23,SZ-23A) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: September 26, 2024 Received: September 26, 2024

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 (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 Rue"). The UDI Rule requires, among other things, that a device bear a unique 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-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-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). 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).

{2}------------------------------------------------

Sincerely,

Digitally signed by Yan Fu -S
Yan Fu -S Date: 2024.11.08 13:45:57
-05'00'

for 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)

K241342

Device Name

Hair Growth Comb (SZ-23,SZ-23A)

Indications for Use (Describe)

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)

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."

{4}------------------------------------------------

510(k) Summary

510(k) number: K241342

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: Shenzhen Nuon Medical Equipment Co., Ltd Establishment Registration Number: 3030541658 Address: 1st Floor-3rd Floor, No. 27-2, Xintang Road, Xintian Community, Fuhai Street, Baoan District, Shenzhen, Guangdong, China

Contact Person (including title): Alain Dijkstra (CEO) Tel: +86-755-82129361 Fax: +86-755-25024651 E-mail: alaindijkstra@nuonmedical.com

2. Subject Device Information

Trade Name: Hair Growth Comb Model:SZ-23, SZ-23A Classification Name: Laser, Comb, Hair (OAP) Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II

3. Predicate Device Information

3.1 Predicate Device 1 (K230579)

Sponsor: Light Tree Ventures Europe B.V. Trade Name: Aduro Comb Classification Name: Laser, Comb, Hair 510(k) Number: K230579 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II

3.2 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 Regulation Number: 21 CFR 890.5500 Regulation Class: II

{5}------------------------------------------------

3.3 Predicate Device 3 (K222477)

Sponsor: Dongguan Lescolton Medical Equipment Co., Ltd Trade Name: Hair Growth Device Classification Name: Laser, Comb, Hair 510(k) Number: K222477 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II

4. Device Description

5. Intended Use / Indications for Use

The Hair Growth Comb (Model: SZ-23, SZ-23A) 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 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 ofComparison	Subject Device	Predicate Device1	PredicateDevice 2	ReferenceDevice	Remark
Company	Shenzhen NuonMedicalEquipment Co.,Ltd	Light TreeVentures EuropeB.V.	Biophotas Inc	DongguanLescoltonMedicalEquipment Co.,Ltd	--
Trade Name	Hair GrowthComb	Aduro Comb(Model: SZ-22A)	BiophotasCellumaRESTORE	Hair GrowthDevice	--
ClassificationName	Laser, Comb,Hair (OAP)	Laser, Comb, Hair(OAP)	Laser, Comb,Hair (OAP)	Laser, Comb,Hair (OAP)	--
510(k) Number	Applying	K230579	K211038	K222477	--
Product Code	OAP	OAP	OAP	OAP	SE
Intended Use /	The hair growth	The Aduro Comb	The BioPhotas	The Hair Growth	SE
Elements ofComparison	Subject Device	Predicate Device1	PredicateDevice 2	ReferenceDevice	Remark
Indications forUse	Comb (Model:SZ-23, SZ-23A)is indicated totreatAndrogeneticAlopecia andpromote hairgrowth in maleswho haveNorwood-HamiltonClassifications ofIla - V patterns ofhair loss and totreatAndrogeneticAlopecia andpromote hairgrowth infemales whohave Ludwig-Savin Scale I-1to I-4, II-1, II-2 orfrontal patternsof hair loss; bothwith FitzpatrickSkin Types I – IV.	(Model: SZ-22A)is indicated totreat AndrogeneticAlopecia andpromote hairgrowth in maleswho haveNorwood-HamiltonClassifications ofIla - V patterns ofhair loss and totreat AndrogeneticAlopecia andpromote hairgrowth in femaleswho have Ludwig-Savin Scale I-1 to1-4, II-1, II-2 orfrontal patterns ofhair loss; bothwith FitzpatrickSkin Types I - IV.	CellumaRESTORE isindicated to treatAndrogeneticAlopecia andpromote hairgrowth in maleswho haveNorwood-HamiltonClassificationsof lla - Vpatterns of hairloss and to treatAndrogeneticAlopecia andpromote hairgrowth infemales whohave Ludwig-Savin Scale I-1to 1-4, II-1, II-2or frontalpatterns of hairloss; both withFitzpatrick SkinTypes I - IV.	Device isindicated topromote hairgrowth in maleswithandrogeneticalopecia whohave Hamilton-NorwoodClassifications ofIla-V andfemales withandrogeneticalopecia whohave Ludwig-SavinClassifications ofI-II andFitzpatrickClassification ofSkin PhototypesI to IV. All usersshould haveFitzpatrick SkinTypes I to IV.
Wavelengths	650±10nm	650±10nm	640nm (±25nm)	650-660nm	SE
Treatment time	Each Treatment:30 minTotal Treatment:every other day,for 16 weeks	Each Treatment:30 minTotal Treatment:every other day,for 16 weeks	EachTreatment:30min TotalTreatment:every other day,for 16 weeks	LS-D620: 20minutes eachtime for 16weeksLS-D630: 12minutes eachtime for 16weeks	SE
Treatment area	31.5 cm²	31.5 cm²	475 cm²	No publiclyavailable	SE
Energy density(mw/cm²)	SZ-23: 2.77mw/cm²SZ-23A:5.54mw/cm²	2.77 mw/cm²	2.77 mw/ cm²	40mW/cm²	SENOTE 1
Elements ofComparison	Subject Device	Predicate Device 1	Predicate Device 2	Reference Device	Remark
TreatmentDose(J/cm²)	SZ-23: 4.98 J/cm²SZ-23A: 9.96 J/cm2	4.98 J/ cm²	4.98 J/ cm²	No publiclyavailable	SENOTE 2
Energy Source	Light emittingdiodes	Light emittingdiodes	Light emittingdiodes	Low-level laserdiodes	SE
Number ofLEDs	SZ-23: 22 LEDsSZ-23A: 11 LEDs	22 LEDs	No publiclyavailable	LS-D620 Laserdiodes: 80LS-D630 Laserdiodes: 162	SE
Power supply	Input: DC 5 V, 2ABattery: DC 3.7V, 600 mAh, 2.22Wh	Input: 100-240V~,50/60Hz,0.35AmaxOutput:5V, 2ABattery: DC 3.7 V,600 mAh, 2.22Wh	110-120V	No publiclyavailable	SE
Location forUse	OTC	OTC	OTC	OTC	SE
Safety andEMC	IEC 60601-1IEC 60601-1-11IEC 62471IEC 60601-2-57IEC 60601-1-2IEC 62133-2	IEC 60601-1IEC 60601-1-11IEC 62471IEC 60601-2-57IEC 60601-1-2IEC 62133-2	IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC 60601-1-11IEC 60601-2-57IEC 60601-1-2IEC 60825-1	SE
Biocompatibility	All patientcontactingmaterials complywith ISO 10993-5, ISO 10993-10	All patientcontactingmaterials complywith ISO 10993-5,ISO 10993-10	All patientcontactingmaterialscomply with ISO10993-5, ISO10993-10	All patientcontactingmaterials complywith ISO 10993-1, ISO 10993-5,ISO 10993-10	SE

{6}------------------------------------------------

{7}------------------------------------------------

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:

ANSI/AAMI ES60601-1: 2005 & A1:2012 & A2:2021 Medical electrical equipment Part 1: General req . uirements for basic safety and essential performance. / IEC 60601-1:2005+AMD1:2012+AMD2:2020 E dition 3.2

{8}------------------------------------------------

� IEC 60601-1-11: 2015+AMD1:2020 Edition 2.1 Medical Electrical Equipment --Part 1: General Require ments for Basic Safety and Essential Performance --Collateral Standard: Requirements for Medical Ele ctrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.
� IEC 60601-2-57: 2023 Edition 2.0 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeuti c, diagnostic, monitoring and cosmetic/aesthetic use.
� IEC 60601-1-2: 2014+AMD1:2020 Edition 4.1 Medical electrical equipment - Part 1-2: General require ments for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
◆ IEC 62471: 2006 First edition Photobiological safety of lamps and lamp systems.
� IEC 62133-2: 2017+AMD1:2021 Edition1.0 Secondary cells and batteries containing alkaline or other n on-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
� IEC 60601-1-6: 2010+AMD1:2013+AMD2:2020 Edition 3.2 Medical electrical equipment - Part 1-6: Ge neral requirements for basic safety and essential performance - Collateral standard: Usability
� IEC 62366-1: 2015+AMD1:2020 Edition 1.1 Medical devices - Part 1: Application of usability engineeri ng to medical devices

2) Biocompatibility

There is one patient directly contracting materials in the subject device as the following list.

Component of	Material of	Body Contact Category(ISO 10993-1)	Contact Duration (ISO10993-1)
Device Requiring	Component
Shell	PC+ABS	Surface-skin	Less than 24 hours

The Nature of body contact is surface, skin contact. And the contact duration is less than 24 hours. According to "Table A.1 - Initial evaluation tests for consideration" in ISO 10993-1, the applicable biological effect is:

Cytotoxicity (ISO 10993-5) �
Sensitization (ISO 10993-10) �
� Irritation or intracutaneous reactivity (ISO 10993-10)

Hair Growth Comb (Model: SA-23, SA-23A) is biocompatible for its intended use. They are complied with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization). So, ISO 10993-5 and ISO 10993-10 test reports have been provided.

{9}------------------------------------------------

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, "Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff" The level of the documentation of the software for was considered as a "basic" level, since a failure or a latent design flaw could directly lead to a minor Injury to the patient or operator.

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.

8.Conclusion:

The proposed device uses technology that is similar to the predicate device. The technology and design do not raise new types of questions regarding safety and effectiveness for the proposed indications for use and the performance testing supports that the device can be used safely and effectively for the proposed indications for use. The proposed device is considered to be substantially equivalent to the predicate device K230579, K211038 and K222477.

Summary Prepared Date:2024-11-7

Version: V5.0

Regulation Number and Section

§ 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.