(355 days)
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.
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.
This 510(k) summary does not contain the detailed study results that would allow for a complete description of acceptance criteria and device performance in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices rather than providing a standalone clinical study report with specific acceptance criteria and detailed performance metrics.
However, based on the provided text, I can infer some information relevant to the request.
Here's an attempt to answer your questions based only on the provided text, with significant limitations due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance results in the form of percentages, p-values, or confidence intervals. The basis for safety and effectiveness is stated as "essentially the same wavelength, the same operation principle, essentially the same fluence levels, and the same spot size" as predicate devices. The indication for "permanent hair reduction" typically implies a specific percentage of hair reduction over a defined period, but this is not quantified in the provided text.
| Performance Metric (Implied) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Hair Reduction Efficacy | Stable long-term or permanent hair reduction, similar to predicate devices. | Stated to achieve "stable long-term, or permanent hair reduction." |
| Treatment of Vascular Lesions | Efficacy similar to predicate devices. | Indicated for the "treatment of vascular lesions." |
| Treatment of Benign Pigmented Lesions | Efficacy similar to predicate devices. | Indicated for the "treatment of benign pigmented lesions." |
| Treatment of Wrinkles | Efficacy similar to predicate devices. | Indicated for the "treatment of wrinkles." |
| Safety Profile | No new questions of safety or efficacy compared to predicate devices. | "The Light Age EpiCare™ Alexandrite Laser... presents no new questions of safety or efficacy, and is substantially equivalent to the predicate devices." Equipped with "safety interlocks to protect patients and operators." |
| Skin Types | Effective and safe for all skin types (Fitzpatrick I-VI) including tanned skin. | Indicated for "all skin types (Fitzpatrick I-VI) including tanned skin." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention any specific sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective/prospective study design). This 510(k) summary relies on demonstrating substantial equivalence to pre-existing predicate devices, not on a new clinical trial with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document does not describe a study involving human experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a study involving adjudication of a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a laser for medical treatments, not an AI diagnostic or assistance system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (laser), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Given the nature of a 510(k) for a laser device, the "ground truth" for its effectiveness would generally be based on clinical outcomes (e.g., observed hair reduction, visual improvement of lesions/wrinkles) from studies (either specifically for this device or, more likely in a 510(k), for the predicate devices) and expert clinical judgment. However, the document does not detail how "ground truth" was established for any specific study for this device. It primarily relies on the established safety and effectiveness of its predicate devices.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device that requires a training set.
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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
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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.
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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.
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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
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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
§ 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.