(153 days)
Not Found
No
The description focuses on standard laser technology and an embedded processor for control, with no mention of AI or ML terms or functionalities.
Yes.
The device is described as "a set of diode lasers... to be used in dermatology for the coagulation of soft tissue," which directly addresses a medical condition or ailment (coagulation of soft tissue in dermatology) with the intent to treat or alleviate it.
No
The device is described as a laser system for the coagulation of soft tissue in dermatological procedures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of "a set of diode lasers, controlled by an embedded processor," and uses "scanning and focusing optics," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Dermatological procedures requiring the coagulation of soft tissue." This describes a procedure performed directly on a patient's tissue, not on a sample taken from the body.
- Device Description: The device description details a laser system that delivers thermal energy to the epidermis and upper dermis. This is a therapeutic or surgical device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Reliant Laser System, as described, is a therapeutic device used to perform a procedure on the patient's tissue.
N/A
Intended Use / Indications for Use
The Reliant Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
Dermatological procedures requiring the coagulation of soft tissue
Product codes
GEX
Device Description
The Reliant Laser System consists of a set of diode lasers, controlled by an embedded processor, to be used in dermatology for the coagulation of soft tissue. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and upper dermis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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NOV 1 0 2003
K031795 1 of 2
510(k) Summary Statement 3
General Information:
As required by Section 12 of the Medical Devices Act of 1990, Reliant Technologies, Inc. has provided a summary of the safety and effectiveness information pertaining to the Reliant Laser System.
| Submitter: | Reliant Technologies, Inc. |
|---|---|
| Address: | 260 Sheridan Ave. |
| Suite 309 | |
| Palo Alto, CA 94306 | |
| Contact Person: | Heather Tanner, Regulatory Affairs |
| Telephone: | (650) 473-0200 ext. 103 |
| Facsimile: | (650) 473-0357 |
| Date prepared: | October 25, 2003 |
| Device Trade Name: | Reliant Laser System |
| Common Name: | Dermatology Laser |
| Classification Name: | Laser Surgical Instrument |
| 21 C.F.R § 878.4810 | |
| Legally Marketed Predicate Devices: | Lumenis Ultrapulse Encore (K022060) |
Description of the Reliant Laser System:
The Reliant Laser System consists of a set of diode lasers, controlled by an embedded processor, to be used in dermatology for the coagulation of soft tissue. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and upper dermis.
Indications for use of Reliant Laser System:
The Reliant Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
Performance Standards:
As a laser product, the Reliant Laser System complies with 21 CFR § 1010 and 21 CFR § 1040.
Statement of Substantial Equivalence:
The Reliant Laser System is substantially equivalent to the cited legally marketed predicate device for the indication listed.
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K031795 2 of 2
References
- Stuzin J, Baker, TJ, Baker, TM, Kligman AM. Histologic Effects of the High-1. Energy Pulsed CO2 Laser on Photoaged Facial Skin Plas & Recon Surg,99(7): 2036-2050 (1997).
-
- Fitzpatrick RE, Goldman MP, Satur NM, Tope WD. Pulsed carbon dioxide laser resurfacing of photoaged facial skin. Arch Dermatol. 1996;132:395-401.
-
- Kirsch, Kristin M. BS. Zelickson, Brian D. MD. Zachary, Christopher B. FRCP. Tope, Whitney D. MPhil, MD. Ultrastructure of Collagen Thermally Denatured by Microsecond Domain Pulsed Carbon Dioxide Laser. Archives of Dermatology. 134(10):1255-1259, October 1998.
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Image /page/2/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 or bird with three lines representing its wings or feathers. To the left of the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2003
Ms. Heather Tanner Clinical Research Reliant Technologies, Inc. 260 Sheridan Avenue, Suite 309 Palo Alto, California 94301
Re: K031795 Trade/Device Name: Reliant 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: October 9, 2003 Received: October 16, 2003
Dear Ms Tanner:
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 mav 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 - Ms. Heather Tanner
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,
Miriam C. Provost
for Colin McWhirter, Ph.D., M.P.
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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1.3 Indications for Use Statement
Premarket Notification [510(k)] Number: K031795
Device Name: Reliant Laser System
Indications for use: Dermatological procedures requiring the coagulation of soft tissue
Miriam C. Provost
(Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K031795
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