The Profile 1064 Laser Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.

Dermatology:

Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.

The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection and reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

Surgical Applications:

Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.

Device Description

Profile Laser System is an Nd:YAG laser producing emission at a wavelength of 1064nm. It consists of a laser console, internal computer, control panel and display, an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.

AI/ML Overview

The provided text describes a 510(k) submission for the Sciton Profile 1064 Laser System, demonstrating its substantial equivalence to previously marketed predicate devices. This type of submission generally relies on demonstrating equivalence rather than conducting new clinical studies with defined acceptance criteria and performance metrics.

Therefore, this document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 as it is a regulatory submission focused on substantial equivalence rather than a study report detailing specific performance criteria, test sets, or training sets for an AI/ML device.

Here's why the information is not present based on the provided text:

Acceptance Criteria and Reported Device Performance (1): The submission focuses on substantial equivalence to predicate devices, meaning its performance is considered acceptable if it is similar to those already on the market. There are no explicit acceptance criteria or a quantitative performance table mentioned.
Sample Size, Data Provenance (2): No new clinical study data with test sets, sample sizes, or data provenance is presented. The argument is based on the similarity of the device's technological characteristics and intended use to existing devices.
Experts, Qualifications, Adjudication (3, 4): These details are relevant for studies establishing ground truth, which is not the primary mechanism of this 510(k) submission.
MRMC Study (5): The submission does not mention an MRMC study or any assessment of human reader improvement with AI assistance, as the device is a laser system, not an AI-assisted diagnostic tool.
Standalone Performance (6): Similar to the above, this concept applies to AI/ML devices, not a laser system.
Type of Ground Truth (7): Ground truth is not established in this context as new clinical validation is not the basis of the submission.
Training Set Sample Size/Ground Truth (8, 9): These concepts are applicable to AI/ML model development. This submission is for a physical medical device (laser system), not an AI algorithm.

In summary, the provided 510(k) summary focuses on demonstrating that the "Profile 1064 Laser System" is substantially equivalent to other legally marketed Nd:YAG laser systems based on shared indications for use and technological characteristics. It is not a report of a study designed to establish new performance criteria or to validate an AI/ML algorithm against a ground truth dataset.

Summary

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KO23881

Attachment IV

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:	November 18, 2002
Device Trade Name:	Profile 1064 Laser System
Common Name:	Nd:YAG Laser System
Classification Name:	Laser Surgical Instrument, 21 CFR 878.4810.
Legally MarketedPredicate Device:	Sciton's laser systems (K002853, K003046 & K010285).Altus Medical Aesthetic Nd:YAG Lasers (K991234,K991798, K003202 and K014040 and K022226);Lyra/Orion Laser Systems manufactured by Laserscope(K990718, K990903, K003147, K003765, K010284,K010834 and K020021);and VeinLase, manufactured by HGM (K981952).
Description ofProfile Laser System:	Profile Laser System is an Nd:YAG laser producingemission at a wavelength of 1064nm. It consists of a laserconsole, internal computer, control panel and display, anoptical delivery system comprised of an articulated armand a handpiece or scanner with cooling capability, and afootswitch.
Intended Use:	The Profile 1064 Laser Systems and Accessories areintended for use in the medical specialties of general andplastic surgery, dermatology, endoscopic/laproscopicgeneral surgery, gastroenterology, gynecology,otorhinolaryngology (ENT), neurosurgery, oculoplastics,orthopedics, pulmonary/thoracic surgery and urology forsurgical and aesthetic applications.

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Dermatology:

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.

The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to. during and after laser treatment, for the epidermal protection and reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

Surgical Applications:

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Rationale for SubstantialEquivalence:	The Profile Laser System and Accessories share the sameindications for use and technological characteristics and istherefore substantially equivalent according to 510(k)quidelines to the above legally marketed predicatedevices.
Safety and EffectivenessInformation:	The above indications for use are based upon theindications for use for predicate laser systems.The technological characteristics are identical to previouspredicate Sciton's laser systems (K002853, K003046 &K010285). As a result, the risks and benefits arecomparable to the predicate devices.We therefore conclude that there are no issues of safety oreffectiveness raised by the introduction of this device.

Rationale for SubstantialEquivalence:

The Profile Laser System and Accessories share the sameindications for use and technological characteristics and istherefore substantially equivalent according to 510(k)quidelines to the above legally marketed predicatedevices.

Safety and EffectivenessInformation:

The above indications for use are based upon theindications for use for predicate laser systems.The technological characteristics are identical to previouspredicate Sciton's laser systems (K002853, K003046 &K010285). As a result, the risks and benefits arecomparable to the predicate devices.We therefore conclude that there are no issues of safety oreffectiveness raised by the introduction of this device.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2003

Mr. Jay M. Patel Director of QA/RA Sciton, Inc. 845 Commercial Street Palo Alto, California 94303

Re: K023881 Trade/Device Name: Profile 1064 Laser Systems and Accessories 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: March 14, 2003 Received: March 17, 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, 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 (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(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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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 yours,

Sincerery, yours,

Mark A. Milkenan

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):	K023881
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Profile 1064 Laser Systems and Accessories Device Name:

Indications for Use:

Dermatology:

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.

Mark n Millers

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

K023881

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Surgical Applications:

(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)

Over-The-Counter Use

Mark N. Millikan

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

510(k) Number _

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.