COSMELIGHT by PENNTACK ENTERPRISES INC.

The Cosmelight Intense Pulsed Light System (and its accessories) are indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, varlous benign pigmente lestons and hair removal as follow:

Intense Pulse Light Energy Wavelengths from 400 - 950 nm are indicated for the reatment of: inflammatory acne.
Intense Pulse Light Energy Wavelengths from 560 - 1200 nm are indicated for the treatment of: benign pigmented (epidermal and coetaneous) lesions including warts, cars and striae. For the treatment of benign (cutaneous) vascular lessons including ort wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider anglormas, poikiloderma of civatte, leg veins, facial veins and venous malformations.
Intense Pulse Light Energy Wavelengths from 700 - 1200 nm are indicated for the treatment of: unwanted hair (i.e., hair removal).

Device Description

The Cosmelight Intense Pulsed Light System is comprised of the following main components:
• A control console unit.
• A control and color display panel.
• Two removable handpieces with an integrated trigger switch and a Cooling System (a cooling device integrated into the handpieces. Quick Cool Handle ( QCH )
• Power supply.

AI/ML Overview

The provided text is a 510(k) summary for the Cosmelight Intense Pulsed Light system. It declares the device to be substantially equivalent to legally marketed predicate devices, rather than presenting a study proving it meets specific acceptance criteria through novel performance data. Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to such a study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with corresponding performance metrics from a specific study of the Cosmelight device. Instead, it relies on the concept of substantial equivalence to predicate devices. The "Performance Data" section states: "The differences in specifications of the Cosmelight system and the Predicate devices do not result in different performance or raise new questions of safety and efficacy." This implies that the performance of the Cosmelight is considered to be on par with the predicate devices, which have already been deemed safe and effective.

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

Not applicable. The document does not describe a clinical study with a test set of data for the Cosmelight device itself. Its submission is based on substantial equivalence.

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

Not applicable. No new ground truth establishment for a test set is described.

4. Adjudication method for the test set:

Not applicable. There is no described test set or adjudication process for the Cosmelight device's performance.

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 an Intense Pulsed Light system, not an AI-powered diagnostic or assistive technology for human readers. Such a study would not be relevant in this context.

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

Not applicable. This is a medical device for treatment, not a standalone algorithm.

7. The type of ground truth used:

Not applicable for the Cosmelight device's submission. The "ground truth" in this context is implicitly established by the prior regulatory clearance and market history of the predicate devices.

8. The sample size for the training set:

Not applicable. The Cosmelight system is not an AI/ML algorithm that requires a training set in the conventional sense. Its development would involve engineering and device testing, not a dataset for model training.

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

Not applicable. No training set is described for this device.

Summary of what can be gleaned from the document regarding "proof of meeting acceptance criteria":

The document's core argument for device acceptance is substantial equivalence to four legally marketed predicate devices:

Lumenis Inc IPL Quantum, K020839
Palomar Inc. EsteLux, K020453
McCue Plc. McCue Energist ULTRA, K040659
DDD A/S, Ellipse I2 PL, K060516

The "Performance Data" section explicitly states that the differences in specifications between the Cosmelight system and these predicate devices "do not result in different performance or raise new questions of safety and efficacy." This implies that the Cosmelight's performance, safety, and efficacy are considered to be equivalent to those predicate devices, which have already "met acceptance criteria" in their respective 510(k) clearances. The FDA's letter (K061720) confirms this by stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."

Summary

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6 1720

Section 3 - 510(k) Summary Re: 061720

JAN 3 1 2007

This 510(k) summary of safety and effectiveness for the Cosmelight Intense Pulsed Light system by Penntack Enterprises Inc. is submitted in accordance with the requirements of the Safe Medical Devise Act (SMDA) of 1990 and follows the office of Devise Evaluation (ODE) guidance concerning the organization and content of a 510(k) summary.

Applicant :	Penntack Enterprises Inc.
Address :	3321 NW 79 ST. Miami, FL 33147
Contact Person :	Paul Pena ( Director )
Telephone :	305-835-0411
Preparation Date :	May 5, 2006
Device Trade Name:	Cosmelight
Common Name :	Intense Pulsed Light System
Classification Name	Laser surgical instrument for use in general and plastic anddermatology.21 CFR 878.4810Product Code: GEXPanel: 79
Legally-marketed	The Cosmelight is substantially equivalent to the following currently
Predicate Devices:	marketed devices:
	Lumenis Inc IPL Quantum, K020839
	Palomar Inc. EsteLux, K020453
	McCue Plc. McCue Energist ULTRA, K040659
	DDD A/S , Ellipse I2 PL, K060516
System Description:	The Cosmelight Intense Pulsed Light System is comprised of thefollowing main components:
	• A control console unit.
	• A control and color display panel.
	• Two removable handpieces with an integrated trigger switchand a Cooling System (a cooling device integrated into thehandpieces. Quick Cool Handle ( QCH )
	• Power supply.
Indicated Use :	The Cosmelight Intense Pulsed Light System (and its accessories)are indicated for use in surgical, aesthetic and cosmeticapplications (requiring photothermolysis, photocoagulation anddermatology) in the treatment of acne, various benign pigmentedlesions and hair removal as follow:
	1. Intense Pulse Light Energy Wavelengths from 400 - 950 nmare indicated for the treatment of acne.
	2. Intense Pulse Light Energy Wavelengths from 560 - 120 0 nmare indicated for the treatment of benign pigmented (epidermal
	and coetaneous) lesions including warts, scars and striae. For thetreatment of benign (cutaneous) vascular lesions including portwine stains, hemangiomas, facial, truncal and leg telangiectasias,rosacea, melasma, angiomas and spider angiormas, poikilodermaof civatte, leg veins, facial veins and venous malformations.
	3. Intense Pulse Light Energy Wavelengths from 700 - 1200 nmare indicated for the treatment of unwanted hair (i.e., hairremoval).
	4. Quick Cool Handle ( QCH )
	The Quick Cool Handle is indicated for use in cooling theepidermis at the treatment Site prior to, during and afterlight or laser treatment in general surgery, plastic surgeryAnd dermatology to :Reduce pain associated with light or laser treatments(via partial anesthesia from Cooling).
	Minimize thermal injury, including thermal necrosis, tonon target skin and skin Structures during light or lasertreatments, thus reducing the possibilities of scabbing,scarring, hypo and / or hyper pigmentation.
	Allows the use of higher light or laser fluences for lightor laser treatments (such as for hair removal and the treatmeof vascular or pigmented lesions.
Performance Data :	The differences in specifications of the Cosmelight system and thePredicate devices do not result in different performance or raisenew questions of safety and efficacy.
Conclusion :	Based on the foregoing, the Cosmelight system is substantiallyEquivalent to the legally-marketed predicate devices mentionedabove.

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|2061720

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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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Penntack Enterprises, Inc. % Mr. Paul Pena Director 3321 NW 79th Street Miami, Florida 33147

JAN 3 1 2007

Re: K061720

Trade/Device Name: Cosmelight 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: GEX Dated: November 24, 2006 Received: November 28, 2006

Dear Mr. Pena:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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.

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Page 2 -- Mr. Paul Pena

This letter will allow you to begin 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

son 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): K061720

Device Name: Cosmelight

Indications for Use:

Intense Pulse Light Energy Wavelengths from 400 - 950 nm are indicated for the reatment of: inflammatory acne.

Intense Pulse Light Energy Wavelengths from 560 - 1200 nm are indicated for the treatment of: benign pigmented (epidermal and coetaneous) lesions including warts, cars and striae. For the treatment of benign (cutaneous) vascular lessons including ort wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider anglormas, poikiloderma of civatte, leg veins, facial veins and venous malformations.
Intense Pulse Light Energy Wavelengths from 700 - 1200 nm are indicated for the treatment of: unwanted hair (i.e., hair removal).

Prescription Use Part 21 CFR 801 Subpart D ) OR

Over-The-Counter Use ( 21CFR 807 Subpart C )

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE

510(k) Number

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

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.