(59 days)
Not Found
No
The summary describes a laser device for hair removal and does not mention any AI or ML components or functionalities.
Yes
The device is described as a medical device for the removal of dark, unwanted body hair, indicating a therapeutic application.
No
The device description and intended use indicate it is used for hair removal, which is a treatment, not a diagnostic purpose.
No
The device description explicitly states it is a "medical device capable of emitting an invisible pulsed treatment laser beam," which is a hardware component.
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 removal of dark, unwanted body hair." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a laser that emits a beam for treatment. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Light Age EpiCare™ Alexandrite Laser is intended for use in dermatology for the removal of dark, unwanted body hair.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Light Age EpiCare™ Alexandrite Laser is a medical device capable of emitting an invisible pulsed treatment laser beam with a wavelength of 755 mm under the guidance of a visible aiming beam. This laser can be utilized in either a continuous or timed-exposure mode of operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dermatology
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): 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.
The Sharplan Model 5000 Alexandrite Laser System (K973354, K971874)
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.
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Page E2
JAN 7 1999
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K9839777
510(k) Summary of Safety and Effectiveness Light Age. Inc. EpiCare™ Alexandrite Laser
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information on which the substantial equivalence determination is based.
The safety and effectiveness of the Light Age EpiCare™ Alexandrite Laser is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device, which is the Sharplan Model 5000 Alexandrite Laser System.
-
- Light Age, Inc. 2 Riverview Drive Somerset, NJ 08873 Susan Laufer, Director of Regulatory Affairs November 5, 1998
-
- Model: Light Age EpiCare™ Alexandrite Laser
- Predicate Device: The Sharplan Model 5000 Alexandrite Laser System (K973354, K971874) 3.
-
- Description: The Light Age EpiCare™ Alexandrite Laser is a medical device capable of emitting an invisible pulsed treatment laser beam with a wavelength of 755 mm under the guidance of a visible aiming beam. This laser can be utilized in either a continuous or timed-exposure mode of operation.
- The Light Age EpiCare™ Alexandrite Laser is intended for use in dermatology for the removal of న్. dark, unwanted body hair.
-
- From both a design and clinical perspective, the predicate and candidate devices are of identical design and have the same intended use. Light Age has been supplying Laser Industries, Ltd. with the internal components of the Sharplan Model 5000 Alexandrite Laser System and integrating them into the basic Laser Industries chassis and power supply since the start of the Model 5000 project. Light Age is now taking over the final assembly, sales, and distribution of this laser. No changes will be made to the product, and Light Age is seeking no new indications in this 510(k) submission.
A letter of authorization from ESC Medical Systems (the parent company of Laser Industries, Ltd. and Sharplan Lasers, Inc.) is provided in Section A of this document, to permit the FDA to access the data contained in K973354 and K971874 in support of this premarket notification.
As the predicate and candidate devices are identical in design and overall performance characteristics, the Light Age EpiCare™ Alexandrite Laser should not raise any concerns regarding its overall safety or effectiveness.
- Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1999 JAN
Ms. Susan Laufer Director of Regulatory Affairs Light Age, Inc. Two Riverview Drive Somerset, New Jersey 08873
K983977 Re: Trade Name: Light Age EpiCare™ Alexandrite Laser Regulatory Class: II Product Code: GEX Dated: November 5, 1998 Received: November 9, 1998
Dear Ms. Laufer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Susan Laufer
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
3
510(k) Number (If known): ____________________________________________________________________________________________________________________________________________________ K983977
Light Age EpiCare™ Alexandrite Laser Device Name:
Indications for Use:
The Light Age EpiCare™ Alexandrite Laser is intended for use in dermatology for the removal of dark, unwanted body hair.
(Please Do Not Write Below This Line - Continue on Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
pcoello
Divisi Division of General Restora 510(k) Numb
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)