(91 days)
No
The summary describes a standard laser hair removal device and explicitly states that AI, DNN, or ML were not mentioned. Performance studies were not required due to substantial equivalence to predicate devices, further indicating a lack of novel AI/ML components.
No
The device is intended for temporary hair removal, which is a cosmetic procedure and not a therapeutic one aimed at treating a disease or condition.
No
The device is described as a hair removal laser, and its intended use is "temporary hair removal," not diagnosis.
No
The device description explicitly states it is a "semiconductor diode laser system," which is a hardware component.
Based on the provided information, the Spectra Hair Removal Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "to effect temporary hair removal." This is a therapeutic or cosmetic purpose, not a diagnostic one. IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a laser system that delivers infrared light. This is a physical treatment modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information.
- Using reagents or assays.
Therefore, the Spectra Hair Removal Laser falls under the category of a therapeutic or cosmetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Spectra Hair Removal Laser is intended to effect temporary hair removal.
Product codes
GEX
Device Description
The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.
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)
None. The specifications and indications for use of the Spectra Hair Removal Laser are a subset of those claimed in one or more of the clearances for the above-listed predicate devices. Thus performance data were not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K973324, K982940, K001746, K010580, K011747, K020849, K030235
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.
0
DEC 1 1 2003
K 032846 1/2
Appendix A. 510(k) Summary
This 510(k) Summary of Safety and Effectiveness for the Spectra Hair Removal Laser is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, and follows the HHS Publication FDA 95-4158 concerning the content and organization of a 510(k) summary.
| Applicant | SpectraGenics, Inc., |
|---|---|
| Address: | 7083 Commerce Circle, Ste. I |
| Pleasanton, CA 94588 | |
| Contact person: | Robert E. Grove, Ph.D. |
| Telephone: | (925) 847-1762 |
| Preparation date: | September 10, 2003 |
| Device Trade Name: | Spectra Hair Removal Laser |
| Common Name: | Pulsed diode laser |
| Classification Name: | Laser Instrument, Surgical, Powered |
| (Laser surgical instrument for use in | |
| general and plastic surgery and | |
| dermatology) | |
| Regulation No. 878.4810 | |
| Product Code: GEX; Panel: 79 | |
| Legally Marketed Predicate Devices: | LightSheer (StarLight) pulsed diode |
| laser | |
| Star Medical / Coherent Star | |
| K973324, K982940, K001746 | |
| SLP 1000 (LC 100) pulsed diode laser | |
| Palomar Medical Technologies | |
| K010580, K011747 | |
| Apex 800 pulsed diode laser | |
| IRIDEX Corporation | |
| K020849 | |
| F1 pulsed diode laser | |
| Opus Medical, Inc. | |
| K030235 |
1
K032846 2/2
| System Description: | The Spectra Hair Removal Laser is a
semiconductor diode laser system that
delivers infrared light at a wavelength of
nominally 800 nm. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use of the Device: | The Spectra Hair Removal Laser is
intended to effect temporary hair removal. |
| Performance Data: | None. The specifications and indications
for use of the Spectra Hair Removal Laser
are a subset of those claimed in one or more
of the clearances for the above-listed
predicate devices. Thus performance data
were not required. |
| Conclusion: | The Spectra Hair Removal Laser is
substantially equivalent to the legally-
marketed claimed predicate devices for the
purposes of this 510(k) submission. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three stripes forming its wings. The eagle is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2003
Robert E. Grove, Ph.D. President and CEO SpectraGenics, Inc. 7083 Commerce Circle, Suite I Pleasanton, California 94588
Re: K032846 Trade/Device Name: Spectra Hair Removal Laser 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: September 5, 2003 Received: September 15, 2003
Dear Dr. Grove:
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.
3
Page 2 - Robert E. Grove, Ph.D.
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
Celia M. Witton, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K032846
Device Name: Spectra Hair Removal Laser
Indications for Use: Temporary hair removal
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTUNUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________