(355 days)
Not Found
No
The summary describes a laser device with a specific wavelength and delivery mechanism. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The description focuses on the physical properties and function of the laser.
Yes
The device is indicated for stable long-term or permanent hair reduction, treatment of vascular lesions, benign pigmented lesions, and wrinkles, all of which address medical conditions or physical processes with a therapeutic intent.
No
The device description and intended use indicate it is an Alexandrite Laser for treatment purposes such as hair reduction, vascular lesions, pigmented lesions, and wrinkles, not for diagnosing conditions.
No
The device description explicitly states it has an Alexandrite crystal rod as a lasing medium and delivers energy via optical fiber with a handpiece, indicating it is a hardware-based laser system, not software-only.
Based on the provided information, the Light Age EpiCare™ Alexandrite Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended uses listed (hair reduction, treatment of vascular lesions, benign pigmented lesions, and wrinkles) are all procedures performed directly on the patient's body. IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health.
- Device Description: The description details a laser that delivers energy to the skin via a handpiece. This is consistent with a therapeutic or cosmetic device used externally, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological specimens.
- Providing diagnostic information based on laboratory tests.
- Using reagents or assays.
Therefore, the Light Age EpiCare™ Alexandrite Laser is a medical device used for external treatments, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Light Age EpiCare™ Alexandrite Laser is indicated for permanent hair reduction, and the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
The Light Age EpiCare™ Alexandrite Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re-growing after a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin.
It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Light Age EpiCare™ Alexandrite Laser has an Alexandrite crystal rod as a lasing medium. Pulsed energy is emitted at 755 nanometers in the near infrared portion of the spectrum. Energy from the laser is delivered to the target area via optical fiber with handpiece, which produces a circular beam on the skin. The EpiCare™ Alexandrite Laser is equipped with safety interlocks to protect patients and operators.
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)
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.
K983977, K024260, K024335 & K024371, K992757, K031488, K971874 & K973354, K003614
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
SEP 1 4 2004
LIGHT AGE, INC.
510(k) Summary of Safety and Effectiveness Light Age EpiCare™ Laser
In accordance with the Safe Medical Devices Act of 1990, 21CFR 807.92, 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™ Laser derives from a I no barry and of substantial equivalence to the predicate devices listed below.
- Light Age, Inc. Applicant: 500 Apgar Dr. , Somerset, NJ 08873 Thomas C. Hauck, Manager of Quality and Process Technology
Date Prepared: Sept. 23, 2003
Description:
The Light Age EpiCare™ Alexandrite Laser has an Alexandrite crystal rod as a lasing medium. Pulsed energy is emitted at 755 nanometers in the near infrared portion of the spectrum. Energy from the laser is delivered to the target area via optical fiber with handpiece, which produces a circular beam on the skin. The EpiCare™ Alexandrite Laser is equipped with safety interlocks to protect patients and operators.
Intended Use:
The Light Age EpiCare™ Alexandrite Laser is indicated for permanent hair reduction, and the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
Model:
Light Age EpiCare™ Alexandrite Laser Trade Name: Common Name: Pulsed Alexandrite Laser
Product Code: GEX
Panel: 79
C.F.R. Section: 878.4810
1
LIGHT AGE, INC.
Classification Pariel: General & Plastic Surgery
Classification:
Medical Device Class: Regulatory Class II
Laser Safety Class: Class IV Laser Product
Predicate Devices:
- Light Age™ EpiCare™ Alexandrite Laser (K983977) -
- CandelaTM GentleLASE Alexandrite Laser (K024260, K024335 & K024371) -
- Cynosure™ Apogee-TKS Alexandrite Laser (K992757) -
- Cynosure™ Apogee-TKS II Alexandrite Laser (K031488) -
- Sharplan™ Model 5000 Alexandrite Laser (K971874 & K973354) -
- Lumenis™ LightSheer™ Pulsed Diode Laser (K003614) *
Description:
The Light Age EpiCare™ Alexandrite Laser has an Alexandrite crystal rod as a lasing The Light Age Loroare - Ancharden 755 nanometers in the near infrared portion of the modial. I ansoc onergy from the laser is delivered to the target area via optical fiber with Spectrum. Lifergy from the hass is a beam on the skin. The EpiCare™ Alexandrite Laser is equipped with safety interlocks to protect patients and operators.
Intended Use:
The Light Age EpiCare™ Alexandrite Laser is indicated for permanent hair reduction, and the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
Safety and Effectiveness:
The Light Age EpiCare™ Alexandrite Laser has essentially the same wavelength, the The Light Age Lpresar - principle of operation, essentially the same fluence levels, and Same sportsize, the bank the predicate devices. The Light Age EpiCare™ Alexandrite the same mention ass new questions of safety or efficacy, and is substantially equivalent to the predicate devices.
Advisory: This information was prepared for the sole purpose of compliance with the Advisory. This information was propession imply that the procedures described herein Salt Mcdroal Do roos Net equipment described without substantial risk of personal injury can oc portomied with the operator error or in procedures requiring a high degree of skill.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 2004
Mr. Thomas C. Hauck Manager of Quality and Process Technology Light Age, Inc. 500 Apgar Drive Somerset, New Jersey 08873
Re: K032991
Trade/Device Name: Light Age EpiCare™ Alexandrite 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: July 28, 2004 Received: July 29, 2004
Dear Mr. Hauck:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your been mind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreated of to the enactment date of the Medical Device Amendments, or to conninered prior to Prial 2011-17-11, in accordance with the provisions of the Federal Food, Drug, de nees mat have been recuire approval of a premarket approval application (PMA). and Cosmeter Fer (110) internet the device, subject to the general controls provisions of the Act. The r ou may, diereleve, mains 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to been at 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 or ury 1 vith 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 forul in the qualis) 25500 provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Thomas C. Hauck
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your to FDA finding of substantial equivalence of your device to a legally premaintent notification " 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 if you attire 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 other general micronational 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. 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
LIGHT AGE, INC.
Indications for Use
510(k) Number (if known): K032991
Device Name: Light Age EpiCare™ Alexandrite Laser
Indications For Use:
The Light Age EpiCare™ Alexandrite Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re-growing after a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin.
It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
Prescription Use X (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)
Miriam C. Provost
Division of General, Restorative, and Neurological Devices
Page 1_of 1
(Posted November 13, 2003) 510(k) Num
510(k) Number kb32991