Lumena FH is an over the counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Lumena FH is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Device Description

Over-The-Counter, AC Powered, Personal Light-Based Hair Removal System. Emission activation is by fingerswitch. Device includes a limited life lamp cartridge. Overall weight of the device is 1.0 Kg, and the size is 22 x 16 x 78 cm (HxWxD). The Principle of Operation is selective photothermolysis and the Mechanism of Operation is to disable hair growth using light to preferentially heat the hair bulb. Electrical Requirement is 115-230 VAC, 50-60 Hz, 1.3A single phase.

AI/ML Overview

The Shaser Lumena FH Hair Removal System (K140631) is an over-the-counter device intended for the removal and permanent reduction of unwanted hair in adults with Fitzpatrick skin types I-IV.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Sufficient label comprehension for safe and appropriate use.	The results of the two tests confirm sufficient label comprehension and safe and appropriate use of the device.
Safe and effective device for intended uses (as safe and effective as the predicate device).	The results of the nonclinical and clinical performance data conclusively demonstrate that the proposed device is at least as safe and effective as the Lumena FH Hair Removal System and is a safe and effective device for the intended uses.

2. Sample Size and Data Provenance

Test Set Sample Size:
- Label comprehension: 150 study subjects.
- Usability test: 123 study subjects.
Data Provenance: The document does not explicitly state the country of origin, but given the FDA submission, it is likely that the study subjects were from the United States. The study appears to be prospective as it involved testing subjects for comprehension and usability.

3. Number of Experts and Qualifications for Ground Truth

The document does not detail the use of experts to establish ground truth for this device's performance in hair removal. The "ground truth" here seems to be the participants' ability to comprehend instructions and use the device safely and appropriately, rather than a clinical outcome measured by experts.

4. Adjudication Method

The document does not describe any adjudication method. For label comprehension and usability tests, adjudication typically isn't applied in the same way as clinical outcome assessments. The "results of the two tests confirm sufficient label comprehension and safe and appropriate use" implies a pass/fail or statistical analysis of the subjects' performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The study focused on label comprehension and device usability by consumers, not on comparing human readers' performance with and without AI assistance for hair removal assessment. This device is a hair removal system, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical light-based hair removal system, not an algorithm. The "performance data" refers to its safety and usability when operated by a human user.

7. Type of Ground Truth Used

The ground truth for the clinical performance data (label comprehension and usability) was based on direct observation and assessment of study subjects' ability to understand instructions and safely operate the device. This is not expert consensus, pathology, or outcomes data in the traditional medical device sense, but rather a behavioral and functional assessment. For the "permanent reduction in unwanted hair" claim, the predicate device's efficacy, measured at 6, 9, and 12 months, serves as the benchmark, implying an outcomes-based ground truth for hair reduction itself, but the current submission focuses on equivalence in safety and usability for the new device.

8. Sample Size for the Training Set

The document does not mention a training set. The clinical performance data presented refers to the evaluation of the device itself (usability and label comprehension), not the training of an algorithm.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set or algorithm is mentioned.

Summary

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K140631 MAY 1 6 7014

510(K) Summary

Submitter:	Shaser, Inc.10 Maguire RoadBuilding 1Lexington, MA 02421
Contact:	Anthony BurnsSenior Director of Regulatory Affairs
Date Summary Prepared:	May 13, 2014
Device Trade Name:	Lumena FH Hair Removal System
Common Name:	Light based hair removal device
Classification Name:	Powered Light Based Non-Laser Surgical Instrument with ThermalEffect. Product Code ONF
Equivalent Device:	Shaser V-MINI 2 Hair Removal System
Device Descripton:	Over-The-Counter, AC Powered, Personal Light-Based Hair RemovalSystem. Emission activation is by fingerswitch. Device includes alimited life lamp cartridge. Overall weight of the device is 1.0 Kg, andthe size is 22 x 16 x 78 cm (HxWxD).The Principle of Operation is selective photothermolysis and theMechanism of Operation is to disable hair growth using light to
	preferentially heat the hair bulb.Electrical Requirement is 115-230 VAC, 50-60 Hz, 1.3A singlephase.
Intended Use:	Removal of unwanted hair.
Indication for Use:	Lumena FH is an over the counter device intended to providephototherapeutic light to the body. It is also intended for removal ofunwanted hair by using a selective photothermal treatment. It is alsoindicated for the removal of unwanted body and/or facial hair in adultswith Fitzpatrick skin types I - IV. The Lumena FH is also intendedfor permanent reduction in unwanted hair. Permanent hair reduction isdefined as the long-term stable reduction in the number of hairsregrowing when measured at 6, 9, and 12 months after the completionof a treatment regimen.
Comparison:	The Lumena FH Hair Removal System has the same indication foruses, the same principle of operation, the same pulse energy range andwavelength range as the Shaser V-MINI 2 Hair Removal System.
Exhibit E - (1 of 3)

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	Proposed Modified Device	Predicate Device 510(k) K133201
Manufacturer	Shaser, Inc.	Shaser, Inc.
Trade Name	Lumena FH Hair Removal System	Shaser V-MINI 2 Hair Removal System
Indications	Lumena FH is an over the counter deviceintended to provide phototherapeutic light tothe body. It is also intended for removal ofunwanted hair by using a selectivephotothermal treatment. It is also indicatedfor the removal of unwanted body and/orfacial hair in adults with Fitzpatrick skintypes I – IV. The Lumena FH is alsointended for permanent reduction inunwanted hair. Permanent hair reduction isdefined as the long-term stable reduction inthe number of hairs regrowing whenmeasured at 6, 9, and 12 months after thecompletion of a treatment regimen.	Shaser V-MINI 2 is an over the counterdevice intended to provide phototherapeuticlight to the body. It is also intended forremoval of unwanted hair by using aselective photothermal treatment. It is alsoindicated for the removal of unwanted bodyand/or facial hair in adults with Fitzpatrickskin types I – IV. The Shaser V-MINI 2 isalso intended for permanent reduction inunwanted hair. Permanent hair reduction isdefined as the long-term stable reduction inthe number of hairs regrowing whenmeasured at 6, 9, and 12 months after thecompletion of a treatment regimen.
'UseClassification'	OTC	OTC
Device Type	Intense Pulsed Light	Intense Pulsed Light
Wavelengthrange (nm)	400nm – 1200nm	400nm – 1200nm
Fluence Settings	1 = 6 (J/cm²)2 = 7 (J/cm²)3 = 8 (J/cm²)4 = 9 (J/cm²)5 = 10 (J/cm²)	1 = 6 (J/cm²)2 = 8 (J/cm²)3 = 10 (J/cm²)
Spot Size (mm)	2cm²	2cm²
Pulse Width (ms)	<200	<200
Time BetweenFlashes (sec.)	<8	<8
Source Energy	AC Mains	Battery
User Interface	LED indicator lights	LCD display with text and graphics
ControlMechanism	Microprocessor-based control	Microprocessor-based control

Exhibit E – (2 of 3)

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Nonclinical Performance Data:	Bench testing for performance verification and electrical safetytesting.
Clinical Performance Data:	Label comprehension and usability test of consumers' ability tounderstand the instructions for use and to evaluate their ability to usethe device safely in a simulated OTC home-use environment.
	• 150 study subjects were tested for label comprehension and 123study subjects tested for usability. Both test populations includedlow literacy subjects.
	The results of the two tests confirm sufficient label comprehensionand safe and appropriate use of the device.
Conclusion:	The results of the nonclinical and clinical performance dataconclusively demonstrates that the proposed device is at least as safeand effective as the Lumena FH Hair Removal System and is a safeand effective device for the intended uses.
Additional Information:	none

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 16, 2014

Shaser Incorporated Mr. Anthony Burns Senior Director of Regulatory Affairs 10 Maguire Road Lexington, Massachusetts 02421

Re: K140631

Trade/Device Name: Lumena FH Hair Removal ystem Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: ONF Dated: April 17, 2014 Received: April 18, 2014

Dear Mr. Burns:

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. 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 (reporting of medical

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Page 2 - Mr. Anthony Burns

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K 14063 I

Device Name

Shaser Lumena FH Hair Removal System

Indications for Use (Describe)

Lumena FH is an over the counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothernal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzparick skin types I - IV. The Lumena FH is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

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

Prescription Use (Part 21 CFR 801 Subpant D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Neil R Ogden -2014.05.15 15:18:48 -

FORM FDA 3881 (1/14)

For BSA

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Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.