The ABC Hair Removal System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.

Device Description

The ABC Hair Removal System is composed of a base unit, umbilical cord, handpiece, chiller system with chiller coolant, cleaning wipes, ABC lubricant, power supply and safety components.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria, reported device performance metrics in a table format, sample sizes used for test sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance data, or training set details.

The document is a 510(k) summary and an FDA clearance letter for the ABC Hair Removal System. It primarily focuses on demonstrating substantial equivalence to predicate devices for its intended use.

Here's a breakdown of what is available and what is not:

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

Not provided. The document states: "The clinical studies demonstrated that the ABC System functions as intended with no serious adverse events." However, no specific performance metrics (e.g., % hair reduction, duration of hair reduction) or acceptance criteria (e.g., "must achieve X% hair reduction in Y% of subjects") are listed.

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

Sample size: Not specified. The document only mentions "Clinical data was collected in a prospective clinical study."
Data provenance: Prospective clinical study. Country of origin is not mentioned.

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 provided. The nature of "ground truth" (e.g., hair counts, expert assessment) is not detailed, nor are any experts mentioned in this context.

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

Not provided.

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 for hair removal, not an AI-assisted diagnostic device requiring human reader interpretation. No MRMC study is mentioned.

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

Not applicable. This is a hardware device for hair removal, not an algorithm. Its "performance" is its ability to remove hair, which is evaluated directly on users.

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

Implied Outcomes Data: The study evaluated "safety and effectiveness." For a hair removal device, effectiveness typically refers to the degree and duration of hair reduction, which would be measured directly (e.g., by hair counting or photographic assessment) as an outcome. However, the specific method used to establish this outcome (e.g., blinded hair counts, subjective patient assessment scale) is not detailed.

8. The sample size for the training set:

Not applicable/Not provided. This is a hardware device, not a machine learning algorithm that requires a training set in the typical sense.

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

Not applicable/Not provided. As above, no training set for an algorithm is discussed.

Summary

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060839

510(k) Summary ABC Hair Removal System

DEC - 7 2006

This 510(k) summary is being submitted in accordance with 21 CFR 807.92

SUBMITTER'S INFORMATION 1.

NAME:	Palomar Medical Technologies, Inc.
ADDRESS:	82 Cambridge Street
	Burlington, MA 01803
	Phone: (781) 993-2300
	Fax: (781) 993-2330
CONTACT:	Sharon Timberlake, RAC, CCRA
	Director, Clinical & Regulatory Affairs

DATE PREPARED: October 26, 2006

2. DEVICE INFORMATION

TRADE/PROPRIETARY NAME:	ABC Hair Removal System
COMMON/USUAL NAME:	Light Based Hair Removal System
CLASSIFICATION NAME:	Laser surgical instrument for use in general andplastic surgery and in dermatology(21 CFR §878.4810)

Product Code: GEX

3. PREDICATE DEVICES

SpaTouch® PhotoEpilation System (K020856) Radiancy (Israel) Ltd.

Spectra Hair Removal Laser (K052848) SpectraGenics, Inc.

Palomar SLP™ 1000 (K013028) Palomar Medical Technologies, Inc.

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060839

4. INTENDED USE

The ABC Hair Removal System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.

ട്. DEVICE DESCRIPTION

The ABC Hair Removal System is composed of a base unit, umbilical cord, handpiece, chiller system with chiller coolant, cleaning wipes, ABC lubricant, power supply and safety components. Details are provided in the Device Description Section of this submission.

PERFORMANCE & CLINICAL DATA 6.

The device complies with the following U.S. Food and Drug Administration performance standards: 21 CFR §1040.10 & 1040.11. Clinical data was collected in a prospective clinical study to support the safety and effectiveness of the ABC Hair Removal System for over-the-counter use. The clinical studies demonstrated that the ABC System functions as intended with no serious adverse events.

7. SUBSTANTIAL EQUIVALENCE

The ABC Hair Removal System is substantially equivalent to its predicate devices when intended for use for hair removal. The data in this 510(k) notification demonstrate that the ABC System shares the same intended use, and similar design features and functional features, and therefore is substantially equivalent to its predicate devices. Details are provided in the Substantial Equivalence Section of this submission.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 1 2008

Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake, RAC, CCRA Director of Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803

Re: K060839

Trade/Device Name: ABC Hair Removal System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHT Dated: July 24, 2006 Received: July 25, 2006

Dear Ms. Timberlake:

This letter corrects our substantially equivalent letter of December 7, 2006.

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 (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.

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); good manufacturing practice requirements as set

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Page 2 - Ms. Sharon Timberlake, RAC, CCRA

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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil R.P. Ogden

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ___ K060839

Device Name: ABC Hair Removal System

Indications for Use:

The ABC Hair Removal System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign-Off Division of General, Restorative. and Neurological Devices

510(k) Number 060835
OR
Over-The-Counter Use X

Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

PALOMAR MEDICAL TECHNOLOGIES, INC. ABC HAIR REMOVAL SYSTEM 510(K)

CONFIDENTIAL

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.