The Bosley Revitalizer 96 Laser Cap is indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.

Device Description

The Bosley Revitalizer 96 Laser Cap consists of 96 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable use with rechargeable battery and adapter. Just as with the Bosley Revitalizer 272 and 164 Laser Caps, the 96 Laser Cap system can detect whether or not the device is in the correct position on the user's head and will automatically pause therapy if it is not. The device will resume therapy when the correct head position is re-established. The system is powered by rechargeable Lithium-ion battery cells assembled into a proprietary battery pack. Both the battery pack and charger are fully compliant with recognized, international standards.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for the Bosley Revitalizer 96 Laser Cap. Based on the document, this is a Special 510(k) submission, meaning the device is a modification of a previously cleared device. Therefore, a new, independent clinical study to prove efficacy and safety against new acceptance criteria was not performed. Instead, the submission relies on the substantial equivalence to predicate devices and verification/validation activities to confirm that the modifications do not introduce new risks or significantly alter performance compared to the original design.

Here's an analysis of the requested information based on the provided text:

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

The document doesn't explicitly state numerical acceptance criteria for a new clinical study. Instead, it relies on the safety and efficacy of its predicate devices. The "performance" assessment is primarily focused on confirming that the modified device (with fewer diodes) still meets established safety standards and that its reduced "dose" is acceptable given the intended indefinite use and lower cost.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with recognized safety standards (e.g., IEC-60601-1)	Conforms to IEC-60601-1, IEC-60601-11, IEC-60601-2-22 (2007/Third Ed.), and IEC60825-1 (Ed. 3). Charger conforms to IEC 61959.
Laser class of 3R, AEL max 5 mW per diode	Laser class 3R, individual diode output ≤ 5mW.
Laser wavelength, output power (per diode), output beam, energy type, laser field, treatment area remain the same as predicate.	Exactly the same laser wavelength (650 nm), output power (per diode), output beam, energy type, laser field, and treatment area as the Bosley Revitalizer 272 and 164 Laser Caps.
No new unacceptable risks due to reduced number of laser diodes	Risk analysis (FMEA) concluded no new unacceptable risk due to reduced number of laser diodes.
Functionality operates as designed	All functions of the modified product have been verified to operate as designed, and all acceptance criteria (for functional verification) were met.
Acceptable efficacy given reduced dose	"Modestly lower efficacy is accepted by users, with the understanding that treatment is intended to be continued indefinitely." Believed that reduced number of laser diodes will only affect the time required to witness the same result.
No reported adverse events	No reported adverse events for these products (Bosley Revitalizer 272 and 164 Laser Caps, and reference devices).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

No new clinical study was conducted for this Special 510(k) submission. The performance assessment relied on verification and validation activities of the modified device and comparison to previously cleared predicate devices. Therefore, there is no "test set" in the context of a new clinical efficacy study, nor explicit sample size or data provenance from such a study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable, as no new clinical study requiring ground truth establishment was conducted for this Special 510(k) submission.

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

Not applicable, as no new clinical study requiring adjudication was conducted for this Special 510(k) submission.

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. The device is a laser cap for hair growth, not an AI-assisted diagnostic tool involving human readers.

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

Not applicable. The device is a hardware device for hair growth, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no new clinical study requiring ground truth was conducted for this Special 510(k) submission. The efficacy claims for the predicate devices would have been based on clinical trials measuring hair growth (e.g., hair count, global photographic assessment), but details of those specific ground truths are not provided in this document.

8. The sample size for the training set

Not applicable, as no new clinical study was conducted. No "training set" in the context of AI or a new clinical trial is mentioned.

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

Not applicable, as no new clinical study was conducted.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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.

PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC % Ronald Berglund Member/Manager Grace Consulting, LLC 6615 Lake Shore Drive, Ste 605 Minneapolis, Minnesota 55423

Re: K192585

Trade/Device Name: Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: December 27, 2019 Received: January 3, 2020

Dear Ronald Berglund:

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 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

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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 (QS) 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.

Jessica Mavadia-Shukla 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) K192585

Device Name

Bosley Revitalizer 96 Laser Cap

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☐ Registration (Part 21 CFR 801, Subpart D)	☑ Over-The-Counter Use (21 CFR 801, Subpart G)
---------------------------------------------	------------------------------------------------

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Special 510(k) Summary

Date: December 27, 2019

Submitter's Contact Information:

Name: Ronald E. Berglund, GRACE Consulting, LLC

Address: 6615 Lake Shore Drive #605, Richfield, MN 55423

Establishment Registration #: 3008855505 Owner/Operator #: 10059366

Telephone: (952)220-3014 Facsimile: (952)888-8282

Name of Device and Name / Address of Sponsor:

Trade Name:	Bosley Revitalizer 96 Laser Cap
Common or Usual Name:	Lamp, non-heating, for promotion of hair growth
Classification Name:	Infrared lamp per 21 CFR 890.5500
Classification Code:	OAP (Laser, Comb, Hair)

Sponsor Contact Information: PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC
1499 Northwest 79th Av., Miami, FL 33126Telephone: (305)477-2515

Predicate Devices:

Illumiflow Laser Cap (K162071)—Cleared for OTC use; Theradome LH80 PRO (K122950)-Cleared for OTC use; Capillus 272, 202 and 82 LLLT Devices (K143199; K150578; K151516; K153618; K163170 and K160285)

Reference Devices:

iGrow-II Hair Growth System (K122248; K140931, additional indication for use in females; K141567, original clearance for use in males) HairMax LaserComb 82 (now sold as the HairMax LaserBand) (K142573, hands-free version of the HairMax LaserComb for use in males and females)

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Intended Use / Indications for Use:

Technological Characteristics

The Bosley Revitalizer 96 Laser Cap incorporates the same technology as the Bosley Revitalizer 272 and 164 Laser Caps in every way except the following:

The Bosley Revitalizer 96 Laser Cap has fewer diodes - 96 compared to 272 and 164 for the Bosley Revitalizer 272 and 164 Laser Caps

The Bosley Revitalizer 272 Laser Cap consists of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer cap and protective inner liner, and configured for portable use with rechargeable battery and adapter. The Bosley Revitalizer 164 Laser Cap consists of 164 red, visible light, diode lasers operating at 650 nanometers, configured within an outer cap and protective inner liner, and configured for portable use with rechargeable battery and adapter. The Bosley Revitalizer 96 Laser Cap consists of 96 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable use with rechargeable battery and adapter. Just as with the Bosley Revitalizer 272 and 164 Laser Caps, the 96 Laser Cap system can detect whether or not the device is in the correct position on the user's head and will automatically pause therapy if it is not. The device will resume therapy when the correct head position is re-established. The system is powered by rechargeable Lithium-ion battery cells assembled into a proprietary battery pack. Both the battery pack and charger are fully compliant with recognized, international standards.

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Design Control Activities:

The Bosley Revitalizer 96 Laser Cap design and development team followed ANSI/AAMI/ISO 14971:2007/(R)2010 Risk Management: Medical devices – Application of risk management to medical devices. Significant changes include assessing the effect a reduction of lasers would have on the end product, both for safety and for efficacy. All residual risks are found acceptable and risk management file and summary are available for review. Based on the Bosley Revitalizer 272 and 164 Laser Caps, the verification and validation activities remain the same (e.g. output of each laser, operation of safety interface, and output of power pack), and were performed and assessed by designated personnel qualified to perform such activities. All methods, tests, and acceptance criteria are stipulated on the verification and validation reports. All documents are available for review.

Safety ratings remained the same; there was no change to the output of the individual lasers (≤ 5mw); however, the "dose" (total delivered energy/cm2) is reduced due to reduced number of lasers. This may affect efficacy; this observation is made based on the performance of other devices similar to Bosley Revitalizer Laser Caps that are currently cleared under device code OAP and utilize much fewer than 272 lasers.

Instructions for use with the Bosley Revitalizer 96 Laser Cap do not change from the instructions provided with the Bosley Revitalizer 272 and 164 Laser Caps. Indications for use and the dose schedule remain exactly the same as for the Bosley Revitalizer 272 and 164 Laser Caps and as for other devices in the same category (product code OAP); which is for maximum 30 minutes, every other day. The output of the laser diodes was verified to remain the same (each diode) as for the previous model. Design control activities were followed per 21 CFR 820.30:

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a) General: The Beijing Toplaser Technology Co., Ltd. Quality Management System is compliant to the requirement of the quality system regulation and specifically to design controls as stipulated by 21 CFR 820.30. The main design activities included the following: 1.) identification of product technical solutions; 2.) risk analysis; and 3.) product validation.
b) Design and development planning: During project planning activities, the risks were identified and assessed with respect to the proposed design change. The proposed design change was minimal and affected only the number of diodes in the PCB array. The power pack remains exactly the same. Review of the risk assessment from the previous models revealed no significant changes or risks identified for the new model Bosley Revitalizer 96 Laser Cap. Vigilance activities for the Bosley Revitalizer 96 Laser Cap indicated that there were no significant problems identified (no adverse events reported).
c) Design input: Design requirements for the Bosley Revitalizer 272 and 164 Laser Caps are transferred to the Bosley Revitalizer 96 Laser Cap and an input/output matrix was completed for the project.
d) Design output: Design requirements for the Bosley Revitalizer 272 and 164 Laser Caps are transferred to the Bosley Revitalizer 96 Laser Cap. Design outputs are verified per performance tests.
e) Design review: Appropriate design reviews were conducted. Due to the minimal modifications made (i.e., only the reduced number of laser diodes), a technical evaluation and a verification of inputs and outputs (physical values) were completed.
f) Design verification: All verification activities to assess the impact of the modification (reduction of number of laser diodes) were completed. It was determined that the laser

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diode output remained the same, but the total dosage is reduced due to the lower number of laser diodes used with the new model. Since the cap is intended to be used indefinitely (if treatment is stopped the results are lost), the reduced number of laser diodes will likely affect only the time required for users to experience the same results as achieved with the Bosley Revitalizer 272 and 164 Laser Caps. The Bosley Revitalizer 96 Laser Cap is offered as a lower-cost alternative to the original models.

g) Design validation: Feedback from hair restoration specialists and consumers indicate that a lower-cost alternative is desired. The modestly lower efficacy is accepted by users, with the understanding that treatment is intended to be continued indefinitely.
h) Design Transfer: The Bosley Revitalizer Laser Cap family of products are manufactured on-site in the facility of the manufacturer in Beijing, China. Design transfer was minimal; training requirement to the new PCB was minimal, and all other components (including overall build) remained the same.
Design changes: The design of all models follows the manufacturer's established design i) control, change control, and document control procedures.
i) Design history: The design history file for the Bosley Revitalizer 96 Laser Cap is available for review.

Performance Data:

All verification and validation activities were performed by designated individuals.

The product design change (reduction of number of laser diodes) was carried out in accordance with the control requirements of design and development activities as detailed in ISO13485 and CFR820, and records of all activities have been maintained.

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The Bosley Revitalizer 96 Laser Cap is a new model modified on the basis of the Bosley Revitalizer 272 and 164 Laser Caps. With the new 96 model the number of laser diodes has been reduced from either 272 or 164 to 96. The parameters of the laser such as wavelength, and output power remain unchanged. The control method, software and usage method also remain the same as with the Bosley Revitalizer 272 and 164 Laser Caps. The risk analysis method utilized was failure modes and effects analysis (FMEA)-- a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. FMEA incorporates each of the following risk analysis components:

"Failure modes" (the ways, or modes, in which something might fail. Failures are any errors or . defects, especially ones that affect the customer, and can be potential or actual);
· "Effects analysis" (refers to studying the consequences of those failures). Failures are prioritized according to how serious their consequences are, how frequently they occur, and how easily they can be detected. The purpose of FMEA is to take actions to eliminate or reduce failures, starting with the highest-priority failures. Failure modes and effects analysis also documents current knowledge and actions about the risks of failures, for use in continuous improvement. FMEA is initially used during design to prevent failures, but after production has begun it is used for control, before and during ongoing operation of the process.

Based on the risk analysis report (Documents No.: FRZ/TZ-YA-12) produced for the Bosley Revitalizer 272 and 164 Laser Caps, the risks caused by the laser diode reduction of this change have been analyzed one by one. The conclusion is that there is no new unacceptable risk due to the reduced number of laser diodes.

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New product samples of the 96-laser diode model have been tested to meet the requirement and the test methods utilized were identical to the test methods utilized for the Bosley Revitalizer 272 and 164 Laser Caps (Test report number: FRZ/JL-T-028). Due to changes in product specifications, the identification label has been modified and new models have been added to the operation manual.

Due to the reduction of the laser diodes, the corresponding product BOM has also been modified. There is, however, no change in the manufacturing process flow. The results of the verification and validation activities (available for review) demonstrate that the predetermined acceptance criteria were met.

Performance testing was conducted to confirm compliance to design specifications. All functions of the modified product have been verified to operate as designed, and all acceptance criteria were met by the new device. The Bosley Revitalizer 96 Laser Cap conforms to the following recognized standards: IEC-60601-1, IEC-60601-11, IEC-60601-2-22 (2007/Third Ed.), and IEC60825-1 (Ed. 3). These IEC standards are recognized and accepted standards by the FDA. The guidance document for these standards is found in the Federal register, July 26, 2001 (volume 66, Number 144). This report validates for the Bosley Revitalizer 96 Laser Cap the laser class of 3R which establishes the AEL (accessible emission limits) as 5 milli Watts maximum. The charger conforms to IEC 61959. The performance data -- available for review-- demonstrates that the Bosley Revitalizer 96 Laser Cap has exactly the same laser wavelength, output power (per diode), output beam, energy type, laser field, and treatment area as the Bosley Revitalizer 272 and 164 Laser Caps cleared under K181253. Total "dose" – delivered energy over time – (J/cm ²) is reduced due to the reduced number of laser diodes. However, since the cap is intended to be used indefinitely (if treatment is stopped, results are lost ), it is believed that the reduced number of laser diodes will

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only affect the time required to witness the same result as achieved with the Bosley Revitalizer 272 and 164 Laser Caps. Just as for the Bosley Revitalizer 272 and 164 Laser Caps (K181253) and reference devices, there have been no reported adverse events for these products.

Substantial Equivalence

The Bosley Revitalizer 96 Laser Cap is the same technology used by Bosley Revitalizer 272 and

164 Laser Caps (K181253) and other reference devices; specifically, iGrow-II Hair Growth

System (K122248 and K140931). The Bosley Revitalizer 96 Laser Cap is as safe and

(commensurate to number of diodes) effective as the Bosley Revitalizer 272 and 164 Laser Caps,

as well as other reference devices in its class, such as the Hairmax Lasercomb.

Bosley Revitalizer96 Laser Cap	Bosley Revitalizer272/164 LaserCaps	IllumiflowLaser Cap	GrivamaxHair GrowthSystem	Capillus272,Capillus202,Capillus82	Ihelmet HairGrowth System	Theradome	200 mm X 200 mm X 112 mm (L X W X H)	180 mm X 180 mm X 95 mm (L X W X H)	OAP Classification	OAP Classification	OAP Classification	OAP Classification	OAP Classification
K192585	K181253	K162071	K171895	K163170,K153618,K160285	K162782	K122950	OAP Classification	OAP Classification	Classification Name - Infrared Lamp	Classification Name - Infrared Lamp	Classification Name - Infrared Lamp	Classification Name - Infrared Lamp	Classification Name - Infrared Lamp
LLLT Device Type	LLLT Device Type	LLLT DeviceType	LLLT DeviceType	LLLT Device Type	LLLT Device Type	LLLT Device Type	Classification Name -Infrared Lamp	Classification Name -Infrared Lamp	Common Usage Name - Lamp, Non-Heating	Common Usage Name - Lamp, Non-Heating	Common Usage Name - Lamp, Non-Heating	Common Usage Name - Lamp, Non-Heating	Common Usage Name - Lamp, Non-Heating
OTC Use	OTC Use	OTC Use	OTC Use	OTC Use	OTC Use	OTC Use	Common Usage Name - Lamp, Non-Heating	Common Usage Name - Lamp, Non-Heating	General & Plastic Surgery Committee	General & Plastic Surgery Committee	General & Plastic Surgery Committee	General & Plastic Surgery Committee	General & Plastic Surgery Committee
Intended Use -AndrogenicAlopecia+promotehair growth	Intended Use -AndrogenicAlopecia+promotehair growth	Intended Use- AndrogenicAlopecia	Intended Use- AndrogenicAlopecia	Intended Use -AndrogenicAlopecia+promotehair growth	Intended Use -AndrogenicAlopecia+promotehair growth	Intended Use -AndrogenicAlopecia in adultfemales	General & Plastic Surgery Committee	General & Plastic Surgery Committee	Fitzpatrick Skin Photo-types - I- IV	Fitzpatrick Skin Photo-types - I- IV	Fitzpatrick Skin Phototypes - I- IV	Fitzpatrick Skin Photo-types - I- IV	Fitzpatrick Skin Phototypes - I- IV
Contain LaserDiodes- Class 3R	Contain LaserDiodes- Class 3R	Contain LaserDiodes- Class3R	Contain LaserDiodes- Class3R	Contain LaserDiodes- Class 3R	Contain LaserDiodes- Class 3R	Contain LaserDiodes- Class 3R	Fitzpatrick Skin Photo-types - I- IV	Fitzpatrick Skin Photo-types - I- IV	Ludwig-Savin I-II (females) Norwood Hamilton IIA-V (males)	Ludwig-Savin I-II (females) Norwood Hamilton IIA-V (males)	Ludwig-Savin I1 to I-4, II-1, II-2, or frontal (females) + Norwood Hamilton Ila-V (males)	Ludwig-Savin 11 to I-4, II-1, II-2, or frontal (females) + Norwood Hamilton Ila-V (males)	Ludwig-Savin I-II (females)
Helmet/CapDesign	Helmet/CapDesign	Helmet/CapDesign	Helmet/CapDesign	Helmet/CapDesign	Helmet/CapDesign	Helmet/CapDesign	Ludwig-Savin I-1 to I-4, II-1, II-2 or frontal (females) Norwood Hamilton IIA-V (males)	Ludwig-Savin I-1 to 1-4, II-1, II-2 or frontal (females) Norwood Hamilton IIA-V (males)	Efficacy Rates - High Compared to Placebo	Efficacy Rates - High Compared to Placebo	Efficacy Rates - High Compared to Placebo
650 nm	650 nm	650 nm	650 nm	650 nm	650 nm	678 nm	Efficacy Rates - High Compared to Placebo	Efficacy Rates - High Compared to Placebo	Treatment- 16 weeks, every other day (30 min. per session)	Treatment- 16 weeks, every other day (30 min. per session)	Treatment- 17 weeks, every other day (indefinite)	Treatment- 16 weeks, every other day (20 – 35 min. per session)	Treatment-20 minutes, twice per week (non-consecutive days)
Marketingclearance formales andfemales	Marketingclearance formales andfemales	Marketingclearance formales andfemales	Marketingclearance formales andfemales	Marketingclearance formales andfemales	Marketingclearance formales andfemales	Marketingclearance forfemales	Treatment- 16 weeks, every other day (indefinite)	Treatment-16 weeks, every other day (indefinite)	Treatment Area:		Treatment Area: Capillus272: 495.37 cm2 Capillus202: 449.51 cm2 Capillus82: 194.42 cm2 Mathematically Max. Derived	Treatment Area: 424.93 cm2 Mathematically Max. Derived
Passive Use-Hands Free	Passive Use-Hands Free	Passive Use-Hands Free	Passive Use-Hands Free	Passive Use-Hands Free	Passive Use-Hands Free	Passive Use-Hands Free	Treatment Area: Bosley 96: 218 cm2 Bosley 96XL: 240cm2 Mathematically Max. Derived	Treatment Area: Bosley272: 509 cm2 Bosley164: 328 cm2 Mathematically Max. Derived	Irradiance (power per area):		Irradiance (power per area): Capillus272: 2.7454 mW/ cm2 Capillus202: 2.2469 mW/cm2 Capillus82: 2.1088 mW/cm2 Mathematically Max. Derived	Irradiance (power per area): 2.3533 mW/ cm2 Mathematically Max. Derived
96 Laser Diodes(5 mW ea.)	272 and 164 LaserDiodes (5 mW ea.)	272 LaserDiodes (5 mW ea.)	272 LaserDiodes (5 mW ea.)	272, 202 and 82Laser Diodes	200 Laser Diodes	80 laser diodes	Irradiance (power per area): Bosley 96: 2.2 mW/ cm2 Bosley 96XL: 2.0 mW/ cm2 Mathematically Max. Derived	Irradiance (power per area): Bosley272: 2.67mW/cm2 Bosley164: 2.5 mW/cm2 Mathematically Max. Derived	Energy Fluence:		Energy Fluence: Capillus272: 4.9417 J/cm2 Capillus202: 4.044 J/cm2 Capillus82: 3.792 J/cm2 Mathematically Max. Derived	Energy Fluence: 4.9420 J/cm2 Mathematically Max. Derived
Dimensions:Bosley 96: 180mmX180 mm X 95mm (L X W X H)Bosley 96Xl:	Dimensions:Bosley 272: 180mm X 180 mm X95 mm (L X W X H)Bosley 164:				Dimensions: 266mm X 196 mm X135 mm (L X W XH)		Energy Fluence: Bosley 96: 3.96 J/cm2 Bosley 96XL: 3.6 J/cm2 Mathematically Max. Derived	Energy Fluence: Bosley272: 4.8 J/cm2 Bosley 164: 4.5 J/cm2 Mathematically Max. Derived	Device Class II	Device Class II	Device Class II	Device Class II	Device Class II
Device Class II	Device Class II		ll

Predicate Comparison Table

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The submitter believes that with the exception of the number of laser diodes and the configuration of the optical elements, the Bosley Revitalizer 96 Laser Cap is the same device in form, function, safety, and efficacy as the previous versions and the predicate device(s). The Hairmax Lasercomb, offered as a reference, is proof of the functionality and acceptability of devices with fewer laser diodes cleared by the FDA in the category of OAP, both technically and clinically. The submitter believes that the difference in the physical appearance, number of diodes, or in the method of delivering the radiant energy of the systems is of no consequence and does not affect the therapeutic value or the safety profile.

All compliant LLLT systems which use red light diode lasers are classified as class 3R laser systems by the IEC standard for allowable emission levels, which is a recognized standard by the FDA as well, and the adverse event profile is the same.

For these reasons, the Bosley Revitalizer 96 Laser Cap satisfies the FDA's requirements (for device modification notification) with respect to intended use, and technological and design characteristics. Additionally, no new safety or efficacy concerns are raised due to the minor differences between these devices.

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.