(165 days)
Not Found
No
The document describes a laser system with a microprocessor-based control unit and a laptop user interface, but there is no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is intended for the treatment of numerous medical conditions, including vascular lesions, benign pigmented lesions, scars, and pseudofolliculitis barbae, which classifies it as a therapeutic device.
No
The device is described as a "surgical instrument" for "treatment" of various dermatological and vascular conditions, not for diagnosis. Its intended use focuses on therapeutic procedures like laser removal, photocoagulation, and reduction.
No
The device description clearly outlines hardware components including a laser source, optical fiber, handpiece, and foot pedal switch, in addition to a microprocessor-based control unit and laptop user interface. This indicates it is a hardware-based medical device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a laser system used for direct treatment of various conditions on the human body (vascular lesions, pigmented lesions, hair reduction, scar reduction, etc.). This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a laser surgical instrument that delivers energy to the target area. This aligns with a therapeutic device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (blood, tissue, etc.), performing tests on these samples, 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-YAG™ Laser System delivers variable pulse laser light in the near infrared portion of the spectrum during procedures.
The Light Age Inc. EpiCare-YAG™ Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign pigmented lesions, for the removal of dark tattoo inks and reduction of hypertrophic and keloid scars and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime on all skin types (Fitzpatrick I-VI including tanned skin.) No new indications were sought in this 510(k) and no clinical data is presented.
Specifically the 1064 nm wavelength is indicated for:
- . Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin.
- . Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins and poikiloderma of civatte. Coagulation and hemostasis of soft tissue.
- . Benign cutaneous lesions such as warts, scars, striae, and psoriasis
- . Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
- Pigmented lesion size reduction in patients with lesions who would potentially . benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
- . Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar
- Treatment of pseudofolliculitis barbae (PFB). .
- Treatment of wrinkles including but not limited to periocular wrinkles and . perioral wrinkles.
Product codes
GEX
Device Description
The Light Age Inc. EpiCare-YAG™ Laser System is a Class IV laser surgical instrument for use in general medical / cosmetic procedures, general and plastic surgery and dermatology. Using neodymium YAG crystal rods, pulsed energy is emitted at 1064 nanometers in the near infrared portion of the spectrum under the guidance of a visible aiming beam. The device consists of the following components and accessories:
-
- Laser source and onboard microprocessor based control unit
-
- Laptop user interface
-
- Flexible optical fiber and handpiece delivers energy from the laser to the target area via optical fiber with handpiece, which produces a circular beam on the skin.
-
- Foot pedal switch activates delivery when lasers are enabled.
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)
No new indications were sought in this 510(k) and no clinical data is presented.
In the nearly one decade of use with over 1 million treatments performed, the EpiCare™ product family has prove to be clinically safe with no reports of significant patient or operator injury.
No new clinical indications are to be provided by the introduction of this device as compared to the predicate devices, identified above, which have previously demonstrated clinical effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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) APR - 3 2012
510(k) Summary
EpiCare-YAG™ Laser System
October 18, 2011
.K113/15 page w of (4)
Submittal Information Post Approval Contact: Dr. Donald F. Heller Chief Executive Officer Elizabeth Reddington Director of Regulatory Affairs Light Age, Inc 500 Apgar Drive Somerset, NJ 08873 Tel: 732-563-0600 Fax: 732-563-1571
Device Name and Classification
510(k) Number: Proprietary Name: Common Name: Classification Name: Classification Panel: C.F.R Section Device Class: Product Code:
Light Age EpiCare-Y AGTM Laser System Nd:YAG Laser System Class IV Laser Surgical Instrument General and Plastic Surgery Devices 878.4810 II GEX
Predicate Devices
Light Age, Inc. EpiCare-DUO™ Laser System (K091625) Candela, Gentle Y AG® (K033172) Cynosure, Apogee Elite™ (K034030)
Device Description
The Light Age Inc. EpiCare-YAG™ Laser System is a Class IV laser surgical instrument for use in general medical / cosmetic procedures, general and plastic surgery and dermatology. Using neodymium YAG crystal rods, pulsed energy is emitted at 1064 nanometers in the near infrared portion of the spectrum under the guidance of a visible aiming beam. The device consists of the following components and accessories:
-
- Laser source and onboard microprocessor based control unit
-
- Laptop user interface
-
- Flexible optical fiber and handpiece delivers energy from the laser to the target area via optical fiber with handpiece, which produces a circular beam on the skin.
-
- Foot pedal switch activates delivery when lasers are enabled.
1
Intended Use:
The Light Age EpiCare-YAG™ Laser System delivers variable pulse laser light in the near infrared portion of the spectrum during procedures.
The Light Age Inc. EpiCare-YAG™ Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign pigmented lesions, for the removal of dark tattoo inks and reduction of hypertrophic and keloid scars and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime on all skin types (Fitzpatrick I-VI including tanned skin.) No new indications were sought in this 510(k) and no clinical data is presented.
The EpiCare-YAG™ has a subset of the capabilities of our EpiCare-DUO™ predicate device. The EpiCare-DUO™ has a modular design format. To create the EpiCare-Y AG™ Light Age, Inc removed the Alexandrite 755nm modules from our previously approved EpiCare-DUO™ Laser System. From both a design and clinical perspective, the predicate and candidate laser devices are of the same technology and have the same intended use. Based on an analysis of the overall performance characteristics for the devices, Light Age, Inc. believes that no significant differences exist.
Specifically the 1064 nm wavelength is indicated for:
- . Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin.
- . Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins and poikiloderma of civatte. Coagulation and hemostasis of soft tissue.
- . Benign cutaneous lesions such as warts, scars, striae, and psoriasis
- . Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
- Pigmented lesion size reduction in patients with lesions who would potentially . benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
- . Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar
- Treatment of pseudofolliculitis barbae (PFB). .
- Treatment of wrinkles including but not limited to periocular wrinkles and . perioral wrinkles.
2
Performance Standards:
- The EpiCare-YAG™ Laser System complies with applicable performance . standards for light emitting products as outlined in 21 CFR 1040.10 and 21 CFR 1040.11.
- . The device also conforms to the voluntary electrical equipment standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-1-22.
Substantial Equivalence
The reason for this 510(K) is a design change. Light Age, Inc has removed some modules (Alexandrite) from our EpiCare-DUO™ Laser System which has been cleared and in use since 2009.
The candidate device operates in 1064 nm wavelength mode and is identical in design and operation to the 1064nm wavelenth mode of the previously EpiCare-DUO™ Laser System.
Safety and Effectiveness
The Light Age EpiCare-YAG™ Laser System should not raise any concerns regarding its overall safety and effectiveness. In the nearly one decade of use with over 1 million treatments performed, the EpiCare™ product family has prove to be clinically safe with no reports of significant patient or operator injury.
The Light Age EpiCare-YAG™ is designed in accordance with both mandatory and voluntary standards ensuring it is both safe and effective for cosmetic / medical procedures indicated above. No new clinical indications are to be provided by the introduction of this device as compared to the predicate devices, identified above, which have previously demonstrated clinical effectiveness.
Indications for Use:
The Light Age Inc. EpiCare-YAG™ Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign pigmented lesions, for the removal of dark tattoo inks and reduction of hypertrophic and keloid scars and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime on all skin types (Fitzpatrick I-VI including tanned skin.) No new indications were sought in this 510(k) and no clinical data is presented.
The EpiCare-Y AGTM has a subset of the capabilities of our EpiCare-DUO™ predicate device. Both systems are modular in design. Light Age, Inc. is removing a capability (Alexandrite 755nm) from our previously approved EpiCare-DUO™ Laser System. From both a design and clinical perspective, the predicate and candidate laser devices are of the same technology and have the same intended use. Based on an analysis of the
3
overall performance characteristics for the devices, Light Age, Inc. believes that no significant differences exist.
Specifically the 1064 nm wavelength is indicated for:
- t Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin.
- . Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins and poikiloderma of civatte. Coagulation and hemostasis of soft tissue.
- . Benign cutaneous lesions such as warts, scars, striae, and psoriasis
- . Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
- . Pigmented lesion size reduction in patients with lesions who would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
- . Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar
- . Treatment of pseudofolliculitis barbae (PFB).
- . Treatment of wrinkles including but not limited to periocular wrinkles and perioral wrinkles.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 3 2012
Light Age, Inc. % Ms. Elizabeth Reddington Director of Regulatory Affairs 500 Apgar Drive Somerset, New Jersey 08873
Re: K113115
Trade/Device Name: Light Age, Inc. EpiCare YAG™ 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: March 30, 2012 Received: April 2, 2012
Dear Ms. Reddington:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 – Ms. Elizabeth Reddington
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE STATEMENT
KII3//5
Device Name: Light Age, Inc. EpiCare-YAGTM Laser System
The Light Age Inc. EpiCare-YAG™ Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign pigmented lesions, for the removal of dark tattoo inks and reduction of hypertrophic and keloid scars and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime on all skin types (Fitzpatrick I-VI including tanned skin.)
Specifically the 1064 nm wavelength is indicated for:
- Removal of unwanted hair, for stable long term or permanent hair reduction on all . skin types Fitzpatrick I-VI including tanned skin.
- Photocoagulation and hemostasis of pigmented and vascular lesions such as but . not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins and poikiloderma of civatte. Coagulation and hemostasis of soft tissue.
- Benign cutaneous lesions such as warts, scars, striae, and psoriasis
- Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar � lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
- Pigmented lesion size reduction in patients with lesions who would potentially . benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity . is an integral part of the scar
- Treatment of pseudofolliculitis barbae (PFB). .
- Treatment of wrinkles including but not limited to periocular wrinkles and . perioral wrinkles.
OR
(Please Do Not Write Below This Line - Continue on Another Page if Needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801 .109) Over the Counter Use
(Optional Format 1-2-06)
Melanil P. Rele for Paul Ozdoba
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113115
Page 12