(81 days)
Not Found
No
The summary describes a standard laser hair removal device and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is intended for temporary hair removal, which is typically considered an aesthetic procedure rather than a therapeutic one addressing a disease or medical condition.
No
The device is described as a hair removal laser, and its intended use is "temporary hair removal," which is a treatment, not a diagnostic process.
No
The device description explicitly states it is a "semiconductor diode laser system" that delivers infrared light, indicating it is a hardware device.
Based on the provided information, the Spectra Hair Removal Laser is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary hair removal." This is a therapeutic or cosmetic procedure performed directly on the patient's body.
- Device Description: It's a laser system that delivers infrared light. This is a physical device used for treatment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. The Spectra Hair Removal Laser does not perform this function.
Therefore, the Spectra Hair Removal Laser is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / Indications for Use
The Spectra Hair Removal Laser is intended for 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 substantially equivalent to those claimed in the clearance for the above-listed predicate devices. Thus performance data were not 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.
K032846, K973324, K982940, K001746, K010580, K011747, K020849, K030235
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
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness for the Spectra Hair Removal Laser is
1000 This STO(K) Sunmary of Safety and Eironerers of the Safe Medical Devices Act of 1990, submitted in accordance with the requires of 1992, and follows the HHS Publication FDA 95the Medical Dortyee 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) 398-2049 |
| Preparation date: | October 5, 2005 |
| 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: | Spectra Hair Removal Laser |
| SpectraGenics, Inc. | |
| K032846 | |
| LightSheer (StarLight) pulsed diode laser | |
| Star Medical / Coherent Star | |
| K973324, K982940, K001746 | |
| SLP 1000 (LC 100) pulsed diode laser | |
| Palomar Medical Technologies, Inc. | |
| K010580, K011747 | |
| Apex 800 pulsed diode laser | |
| Iridex Corporation | |
| K020849 |
1
| | F-1 pulsed diode laser
Opusmed, Inc.
K030235 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
for temporary hair removal. |
| Performance Data: | None. The specifications and indications for
use of the Spectra Hair Removal Laser are
substantially equivalent to those claimed in
the clearance 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 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 perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 7 2005
Mr. Robert E. Grove, Ph.D. President & CEO Spectragenics, Inc. 5880 West Las Positas Blvd., Suite 52 Pleasanton, California 94588
Re: K052848
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: October 5, 2005 Received: October 12, 2005
Dear Dr. Grove:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section 510(x) prematice insubstantially equivalent (for the indications referenced above and nave ucterimined the acress as edicate devices marketed in interstate for use stated in the encrosule) to regally mancede producal Device Americal Device Ameradments, or to commerce prior to May 28, 1770, the chasinon and ever sions of the Federal Food, Drug, devices that have been recarsined in accordance will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previoione of the Act and Cosmetic Act (Act) that do not require upproval of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general contr You may, therefore, market the device, subject to general registration, listing of
general controls provisions of the Act include requirements for annual registration and general controls provisions of the rectments requirements of and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (See above) into entile chass regulations affecting your device
it may be subject to such additional controls. Existing major regulations all t it may be subject to such additional controls: "Zholing may be of the 200 to 898. In addition, FDA can be found in the Code of Federal regerming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that I DA s Issuality of a succeannal requirements of the Act
that FDA has made a determination that your device complies with other must that I'DA has made a delemination mac Jour as roo by other Federal agencies. You must
or any Federal statutes and regulations administered by other Federal agencies. You ma or any Federal Statures and regulations administered of registration and listing (21 comply with an the Act 3 requirements, news 801); good manufacturing practice requirements as settem CFK Part 807); labeling (21 CFR Part 801); good manart 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 GFR 1900 form in the quality systems (Q5) regulantin (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Dr. Grove
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of the p premarket notification. "The I DA miding of Justication 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 If you desire specific advice for your accessor and the regulation entitled, the regulation entitled, Contact the Office of Compulation at (210) 210-07-27 Part 807.97). You may obtain "Misbranding by relerence to premarket noutheation" (2) of from the Division of Small other general Information on your responsion.com at its toll-free number (800) 638-2041 or 1 Manufacturers, International and Consumer Problement of arch/industry/support/index.html.
Sincerely yours,
Barbara Buehrle
Mark N. Melkerson Acting 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):
Device Name:
Spectra Hair Removal Laser
Indications For Use:
The Spectra Hair Removal Laser is intended for temporary hair removal.
Prescription Use _ レ (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)
Starlane Buckup for mmy
Division of General, Restorative. and Neurological Devices
Page 1 of
510(k) Numb
umber K052848