(19 days)
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No
The document describes a pulsed light device for aesthetic treatment and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is indicated for the treatment of benign pigmented lesions, which is an aesthetic purpose, not a therapeutic one. Therapeutic devices typically aim to cure, mitigate, treat, or prevent disease, or affect the structure or any function of the body for health-related purposes.
No
The device is indicated for treatment (benign pigmented lesions) and is a pulsed light device, not designed for diagnosis.
No
The device description explicitly lists multiple hardware components, including a console, hand piece, footswitch, and remote interlock connector, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of benign pigmented lesions." This is a therapeutic application, not a diagnostic one. IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a pulsed light system designed to deliver energy to the skin. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, preparing, or analyzing biological specimens.
Therefore, the Cutera Flashlamp Tabletop Aesthetic Product is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cutera Flashlamp Tabletop Aesthetic Product is indicated for the treatment of benign pigmented lesions.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Cutera Flashlamp Tabletop Aesthetic Product consists of a modified console designed to drive the pulsed light hand pieces, which are all existing, FDA cleared devices. The hand pieces are pulsed light devices with a variable emission of 500-1300nm. The delivered wavelength is filtered to various desired wavelength bands within the 500-1300nm range via coated glass filters to eliminate the extraneous wavelengths. The Cutera Flashlamp Tabletop Aesthetic Product is comprised of five main components:
- a system console (including software and control electronics);
- a control and display panel;
- a detachable hand piece with integrated skin cooling;
- a foot-operated exposure switch (footswitch); and
- a remote interlock connector (disables emission when treatment room door is opened).
The proximal end of the umbilical cable is semi-permanently attached to the system console and the distal end is permanently attached to the body of the delivery hand piece. This hand piece is removable by either the user or an authorized field service engineer for replacement at the proximal end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical data is required.
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.
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).
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§ 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
Ko50069
Premarket Notification 510(k) Submission: Cutera Flashlamp Tabletop Aesthetic Product JAN ? 1 2005
Attachment 12 510(k) Summary for the Cutera Flashlamp Tabletop Aesthetic Product
General Information l.
| Submitter: | Cutera, Inc. |
|---|---|
| 3240 Bayshore Boulevard | |
| Brisbane, CA 94005 |
Kathy Maynor Contact Person:
Summary Preparation Date: November 19, 2004
II. Names
Cutera Flashlamp Tabletop Aesthetic Product Device Names:
(and Powered Surgical Instrument Primary Classification Name: Laser Accessories) 878.4810 - GEX
III. Predicate Devices
- Cutera CoolGlide Aesthetic Lasers With Optional Pulsed Light Hand Piece . (K023954)
- Cutera Titan Tabletop Product (K042165) .
IV. Product Description
The Cutera Flashlamp Tabletop Aesthetic Product consists of a modified console designed to drive the pulsed light hand pieces, which are all existing, FDA cleared devices. The hand pieces are pulsed light devices with a variable emission of 500-1300nm. The delivered wavelength is filtered to various desired wavelength bands within the 500-1300nm range via coated glass filters to eliminate the extraneous wavelengths.
The Cutera Flashlamp Tabletop Aesthetic Product is comprised of five main components:
- · a system console (including software and control electronics);
- a control and display panel;
1
cfo069
Premarket Notification 510(k) Submission: Cutera Flashlamn Tableton Aesthetic Product
- · a detachable hand piece with integrated skin cooling;
- · a foot-operated exposure switch (footswitch); and
· a remote interlock connector (disables emission when treatment room door is opened).
The proximal end of the umbilical cable is semi-permanently attached to the system console and the distal end is permanently attached to the body of the delivery hand piece. This hand piece is removable by either the user or an authorized field service engineer for replacement at the proximal end.
V. Indications for Use
The Cutera Flashlamp Tabletop Aesthetic Product is indicated for the treatment of benign pigmented lesions.
VI. Rationale for Substantial Equivalence
The Cutera Flashlamp Tabletop Aesthetic Product shares the same general indications for use, and therefore is substantially equivalent to the currently cleared pulsed light hand piece (K023954) and the currently cleared tabletop console (K042165). No clinical data is required.
VII. Safety and Effectiveness Information
The indication for use is exactly the same as the previously cleared pulsed light hand piece (K023954).
Technologically, the Cutera Flashlamp Tabletop Product is substantially equivalent to the listed predicate devices. Therefore the risks and benefits for the Cutera Flashlamp Tabletop Product are comparable to the predicate devices.
We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of this device.
VIII. Conclusion
The Cutera Flashlamp Tabletop Aesthetic Product was found to be substantially equivalent to the currently cleared Cutera pulsed light hand piece (K023954) and Cutera tabletop console (K042165). The Cutera Flashlamp Tabletop Aesthetic Product shares similar indications for use, design features, and similar functional features as, and thus is substantially equivalent to the currently marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2005
Cutera, Inc. c/o Mr. Morten Simon Christensen Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050
Re: K050069
Trade/Device Name: Cutera Flashlamp Tabletop Aesthetic Product 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: January 11, 2005 Received: January 12, 2005
Dear Mr. Christensen:
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 1:sting (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 c'.cctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Morten Simon Christensen
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Muriam C. Provost
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
4
Premarket Notification 510(k) Submission: Cutera Flashlamp Tabletop Aesthetic Product
Attachment 2 Indications For Use Statement as Requested by FDA
510(k) Number (if Known): _ _ KOS 006 9
Device Name: Cutera Flashlamp Tabletop Aesthetic Product
Indications For Use:
The Cutera Flashlamp Tabletop Aesthetic Product is intended for the treatment of benign pigmented lesions.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K050069