(774 days)
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description focuses on standard laser and sensor technology.
No.
The device is intended for hair removal, which is a cosmetic procedure, not a therapeutic one.
No
A diagnostic device is used to identify a disease, condition, or injury. This device is intended for hair removal, which is a cosmetic procedure, not a diagnostic one. While it has a sensor to determine safe use, this is a safety feature, not a diagnostic function in the medical sense.
No
The device description explicitly states it consists of a "Spectra Hair Removal Laser" and a "Spectra Skin Sensor," 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 for hair removal, which is a physical treatment applied to the body. IVDs are used to examine specimens taken from the body (like blood, urine, tissue) to provide information about a person's health or condition.
- Device Description: The device is a laser system that delivers light. While it includes a sensor, the sensor's purpose is to determine safe usage of the laser, not to analyze a biological sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Spectra Hair Removal Laser System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spectra Hair Removal Laser System is an overthe-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.
Product codes
GEX
Device Description
The Spectra Hair Removal System consists of the Spectra Laser and Spectra Skin Sensor. The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm. The Spectra Skin Sensor determines whether users can safely use the Spectra Hair Removal Laser.
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)
Clinical data is provided to demonstrate the safety and efficacy of the Spectra Hair Removal Laser System in a simulated home-use environment to support the over-the-counter clearance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K032846, K052848, K973324, K982940, K001746, K013028, K010580, K011747, K020849
Reference Device(s)
K030235, K020856, K020856, K030897, K051671, K060839
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
510(k) Summary of Safety and Effectiveness
KOS 3527
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: | 5880 W. Las Positas Blvd., Suite 52 | |
| Pleasanton, CA 94588-8552 | ||
| Contact person: | Robert E. Grove, Ph.D. | |
| Telephone: | (925) 701-2549 | FEB - 1 2007 |
| Preparation date: | December 3, 2007 | |
| Device Trade Name: | Spectra Hair Removal Laser System | |
| 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: | Spectra Hair Removal Laser | |
| SpectraGenics, Inc. | ||
| K032846, K052848 |
LightSheer (StarLight) pulsed diode laser
Star Medical / Coherent Star
K973324, K982940, K001746
SLP 1000 (LC 100) pulsed diode laser
Palomar Medical Technologies, Inc.
K013028, K010580, K011747
Apex 800 pulsed diode laser
Iridex Corporation
K020849 | |
1
F-1 pulsed diode laser Opusmed, Inc. K030235
SpaTouch® PhotoEpilation System Radiancy (Israel) Ltd. K020856
SpaTouch Pro PhotoEpilation System Radiancy (Israel) Ltd. Presumed to be K020856
SkinTouch Radiancy (Israel) Ltd. K030897, K051671
ABC Hair Removal System Palomar Medical Technologies, Inc. K060839
The Spectra Hair Removal System consists of the Spectra Laser and Spectra Skin Sensor. The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm. The Spectra Skin Sensor determines whether users can safely use the Spectra Hair Removal Laser.
The Spectra Hair Removal Laser System is an overthe-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.
The specifications and indications for use of the Spectra Hair Removal Laser System are substantially equivalent to those claimed in the clearance for the above-listed predicate devices.
Clinical data is provided to demonstrate the safety and efficacy of the Spectra Hair Removal Laser System in a simulated home-use environment to support the over-the-counter clearance.
System Description:
Intended Use of the Device:
Performance Data:
2
Conclusion:
The Spectra Hair Removal Laser System is substantially equivalent to the legally-marketed
claimed predicate devices for the purposes of this 510(k) submission.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird with three distinct lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird, with the words separated by dots.
FEB - 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SpectraGenics, Inc. % Robert E. Grove, Ph. D. President & CEO 5880 West Las Positas Boulevard Pleasanton, California 94588
Re: K053527
Trade/Device Name: Spectra Hair Removal 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: Class II Product Code: GEX Dated: August 08, 2007 Received: August 13, 2007
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. 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 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.
4
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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Mullerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ___ K053527
Device Name:
Spectra Hair Removal Laser System
Indications For Use:
The Spectra Hair Removal Laser System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.
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-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division S gn=(){{ Division of General, Restorative, and Neurological Devices
510(k) Number | 1053527