The Profile BBL (and the light and/or laser delivery accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
It is intended for use for:
• The treatment of tattoos;
• The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
• The treatment of cutaneous lesions including warts, scars and striae;
• The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, engiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
• Treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis; and
• The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction.
The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
• Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
• Reduce discomfort during and/or associated with light or laser treatment:
• Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
• Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
• Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Device Description

Profile BBL System emits intense wide spectrum emission with wavelength of 500-1400 nm. It consists of a system console, internal computer, control panel and display, and a treatment head comprised of a light guide with cooling capability and a pushbutton switch.

AI/ML Overview

The provided text is a 510(k) summary for the Sciton Profile BBL System. It establishes substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

This document focuses on the regulatory aspects of device clearance, asserting equivalence based on similar indications for use, design features, and functional features compared to previously cleared devices. It does not present novel performance data or detail any studies designed to meet specific acceptance criteria for the Sciton Profile BBL System itself.

Therefore, the requested information, such as a table of acceptance criteria and device performance, sample sizes, expert qualifications, ground truth details, or MRMC study results, cannot be extracted from the provided text.

Summary

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NOV 1 3 2003

Attachment IV

K032460

510(k) Summary

Submitter:	Sciton, Inc.
Address:	845 Commercial Street, Palo Alto, CA 94303
Phone:	(650) 493-9155
Fax :	(650) 493-9146
Contact Person:	Jay M. Patel, Director of Regulatory Affairs
Date Prepared:	July 31, 2003
Device Trade Name:	Profile BBL System
Common Name:	Laser Powered Surgical Device (and Accessories)
Classification Name:	Laser Surgical Instrument, 21 CFR 878.4810.
Legally MarketedPredicate Device:	Lumenis Family of Intense Pulsed-Light (KO30527,K020839)Palomar EsteLux (K020453)Altus Medical CoolGlide with Optional Pulsed Light HandPiece (K023954)
Description ofProfile BBL System:	Profile BBL System emits intense wide spectrumemission with wavelength of 500-1400 nm. It consists of asystem console, internal computer, control panel anddisplay, and a treatment head comprised of a light guidewith cooling capability and a pushbutton switch.
Intended Use:	The Profile BBL (and the light and/or laser deliveryaccessories) is indicated for use in surgical, aesthetic andcosmetic applications requiring selective photothermolysis(photocoagulation or coagulation) and hemostasis of softtissue in the medical specialties of general and plastic surgeryand dermatology.It is intended for use for:• The treatment of tattoos;• The treatment of benign pigmented lesions includingdyschromia, hyperpigmentation, melasma, ephelides(freckles);• The treatment of cutaneous lesions including warts, scarsand striae;
	• The treatment of benign cutaneous vascular lesions,including port wine stains, hemangiomas, facial, truncal andleg telangiectasias, rosacea, erythema of rosacea, engiomasand spider angiomas, poikiloderma of Civatte, leg veins andvenous malformations;
	• Treatment of psoriasis, vitiligo, atopic dermatitis (eczema),seborrheic dermatitis; and
	• The removal of unwanted hair from all skin types, and toeffect stable long-term, or permanent, hair reduction.
	The integral thermo-electric cooler is indicated for use incooling the epidermis at the treatment site prior to, during andafter light or laser treatment in general surgery, plastic surgeryand dermatology to:
	• Reduce pain during and/or associated with light or lasertreatment (via partial anesthesia from cooling);
	• Reduce discomfort during and/or associated with light orlaser treatment:
	• Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated withlight or laser treatment, thus reducing possible complicationssuch as scabbing, scarring, hyper- and/or hypopigmentation;
	• Allow the use of higher light or laser fluences for light orlaser treatments (such as for hair removal and the treatmentof vascular or pigmented lesions); and
	• Reduce potential side effects of light or laser treatments(such as for hair removal and the treatment of vascular orpigmented lesions).
Rationale for SubstantialEquivalence:	The Profile BBL Laser System shares the sameindications for use, similar design features (includingwavelength, laser medium, power supply, cooling andcontrol system), functional features (including poweroutput, repetition rate, energy, spot size and fluence), andis therefore substantially equivalent to the above legallymarketed predicate devices.
Safety and EffectivenessInformation	The indications for use are based upon the indications foruse for predicate systems. Technologically, the Profile BBLsystem is substantially equivalent to the listed predicatedevices. Therefore, the risks and benefits for the ProfileBBL system are comparable to the predicate devices.
Conclusion	The Profile BBL shares similar indications for use, designfeatures, and similar functional features as, and thereforeis substantially equivalent to, the currently marketedpredicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare. The caduceus is depicted with three lines forming a shape resembling a bird or a stylized human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2003

Mr. Jay M. Patel Director of Regulatory Affairs Sciton, Inc. 845 Commercial Street Palo Alto, California 94303

Received: August 16, 2003

Re: K032460

Trade/Device Name: Profile BBL 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: GEX Dated: July 31, 2003

Dear Mr. Patel:

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. Iisting 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 docs 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 (OS) 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. Jay M. Patel

This letter will allow you to begin marketing your device as described in your Section 510/kg 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 80) ). please contact the Office of Compliance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark N. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment III

Statement of Indications for Use

510(k) Number (if known): K032460

Profile BBL System Device Name:

Indications for Use:

It is intended for use for:

. The treatment of tattoos;
The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, . ephelides (freckles);
. The treatment of cutaneous lesions including warts, scars and striae;
The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, engiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
Treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis; and ●
The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair ● reduction.

The integral thermo-electric cooler is indicated for use in cooling the epidernis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:

Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from ● cooling);
Reduce discomfort during and/or associated with light or laser treatment;
. Minimize thermal injury, including thermal necrosis, to non-farget skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
. Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
. Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21CFR801)	✓	OR	Over-The-Counter Use
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for

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

510(k) Number	K032960
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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.