(159 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the laser technology and its components.
Yes
The device is intended for medical treatments such as incision, excision, ablation, vaporization, coagulation of soft tissue, and treatment of wrinkles, which are therapeutic interventions.
No
The device is described as a laser system for surgical procedures (incision, excision, ablation, vaporization, coagulation) and treatment of wrinkles, which are therapeutic rather than diagnostic applications.
No
The device description clearly outlines hardware components such as a laser console, internal computer, control panel, display, optical delivery system (articulated arm, handpiece/scanner), and a footswitch. This indicates it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a laser system used for surgical procedures (incision, excision, ablation, vaporization, coagulation) and cosmetic treatments (wrinkle treatment) on soft tissue. This involves direct interaction with the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are performed outside of the body.
- Device Description: The description details a laser system with an articulated arm and handpiece, designed for delivering laser energy to the patient. This is consistent with a surgical or dermatological device, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the Sciton, Inc. Profile 1320 Laser is a therapeutic and surgical device, not an in vitro diagnostic device.
N/A
Intended Use / 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 also indicated for the treatment of periorbital and perioral wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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 display, an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, periorbital, perioral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
general surgery and dermatology
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K003715 and K014035 Cooling Touch Nd:YAG Laser System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
022 466
SCITON
DEC 3 1 2002
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: | July 23, 2002 |
| Device Trade Name: | Profile 1320 Laser System |
| Common Name: | Nd:YAG Laser System |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Legally Marketed | |
| Predicate Device: | CoolTouch Nd:YAG Laser System (K003715 and |
| K014035) | |
| Description of | |
| Profile 1320 Laser System: | 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 display, an | |
| optical delivery system comprised of an articulated arm | |
| and a handpiece or scanner with cooling capability, and a | |
| footswitch. | |
| Intended 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 also indicated for the treatment of periorbital | |
| and perioral wrinkles. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 31 2002
Sciton, Inc. Jay M. Patel Director of Regulatory Affairs 845 Commercial Street Palo Alto. California 94303
Rc: K022466
Trade/Device Name: Profile 1320 Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument Regulatory Class: Class II Product Code: GEX Dated: October 30, 2002 Received: November 1, 2002
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 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
2
Page 2 - Mr. Jay M. Patel .
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.
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). 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Purret
for 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
3
Attachment III
Statement of Indications for Us
K022466 510(k) Number (if known):
Profile 1320 Laser System Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Profile 1320 Laser System is intended for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles.
(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 |
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices