(211 days)
The Sciton, Inc. Profile 1320 Laser is intended for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue. It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.
Profile 1320 Laser System is an Nd:YAG laser producing emission at a wavelength of 1320 nm. It consists of a laser console, internal computer, control panel and displav. an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.
The provided text is related to a 510(k) premarket notification for a medical device called the "Profile 1320 Laser System." This document establishes the substantial equivalence of the device to existing predicate devices based on design, functional features, and intended use.
Based on the provided text, there is no information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. The document focuses on regulatory compliance through substantial equivalence to predicate devices, rather than detailed performance metrics or clinical study results as you would expect for AI/ML device evaluations.
Therefore, I cannot fulfill your request for the specific details outlined (points 1-9) because the necessary information is not present in the provided 510(k) summary. This type of regulatory submission typically does not include the detailed performance study information you are asking for if the device is deemed substantially equivalent to a predicate device.
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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: | August 1, 2003 |
| Device Trade Name: | Profile 1320 Laser System |
| Common Name: | Nd:YAG Laser System |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Legally MarketedPredicate Device: | Profile 1320 Laser System (K022466, K022381)CoolTouch Nd:YAG Laser System (K031184, K030453K022817, K014035 and K012982)Candela Smoothbeam Laser System (K022884, K014128and K013825) |
| Description ofProfile 1320 Laser System: | Profile 1320 Laser System is an Nd:YAG laser producingemission at a wavelength of 1320 nm. It consists of a laserconsole, internal computer, control panel and displav. anoptical delivery system comprised of an articulated armand a handpiece or scanner with cooling capability, and afootswitch. |
| Intended Use: | The Sciton, Inc. Profile 1320 Laser is intended for use ingeneral surgery and dermatology for the incision, excision,ablation, vaporization, coagulation, with hemostasis of softtissue. It is indicated for the treatment of fine lines andwrinkles. It is also indicated for the treatment of back acneand atrophic acne scars. |
| Rationale for SubstantialEquivalence: | The Profile 1320 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), and |
| is 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 Profile1320 Laser System is substantially equivalent to the listedpredicate devices. Therefore, the risks and benefits for theProfile 1320 Laser System are comparable to the predicatedevices. |
| Conclusion | The Profile 1320 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 Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white and has a simple, clean design.
MAR - 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jay M. Patel Director of Regulatory Affairs Sciton, Inc. 845 Commercial Street Palo Alto, California 94303
Re: K032459 Trade/Device Name: Profile 1320 Laser 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: December 10, 2003 Received: December 12, 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 (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. 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. 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 yours,
Sincerely yours,
Mark N Milliman
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): ____________________________________________________________________________________________________________________________________________________
Device Name: ___
Frofile 1320 Laser System
Indications for Use:
The Sciton, Inc. Profile 1320 Laser is intended for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue.
It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.
(The indications for use in this paragraph are new per this 510k.)
(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
. Restoral ve. and Neurological Devices
510(k) Number K03245
§ 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.