(153 days)
The Light Age, Inc. EpiCare-DUO™ Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign pigmented lesions, for 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.
Light Age, Inc. is providing more specialized indications which are a subset of the previously cleared indications. 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 upon an analysis of the overall performance characteristics for the devices, Light Age, Inc. believes that no significant differences exist.
755nm - Specifically the 755 nm mode is indicated
- Hair removal, and stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles on all skin types (Fitzpatrick I-VI) including tanned skin. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime. The number of hairs re-growing must be stable over a time greater than the duration of the complete growth cycle of hair follicies, which varies from 4-12 months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treated area.
- Treatment of vascular lesions
- Treatment of benign pigmented lesions.
- Treatment of wrinkles.
1064nm -
- 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, hemoangioma, 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 striac and psoriasis.
- Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheio keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plagues.
- 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 periocular wrinkles and perioral wrinkles,
No new indications were sought in this premarket notification and no clinical data is presented.
Light Age, Inc. is providing more specialized indications which are a subset of the previously cleared indications. 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 upon an analysis of the overall performance characteristics for the devices, Light Age, Inc. believes that no significant differences exist.
The Light Age EpiCare-DUO™ Laser is a Class IV Laser Surgical Instrument for use in General medical/cosmetic procedures, General and Plastic surgery, Podiatry, and Dermatology. Using alexandrite and neodymium (Nd) YAG crystal rods, pused energy is emitted at 755 and 1064 nanometers in the near infrared portion of the spectrum under the guidance of a visible aiming beam. The device consists of the fploving 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 bearn on the skin.
- Foot Pedal Switch activates delivery when lasers are enabled.
The provided text is a 510(k) summary for the Light Age EpiCare-DUO™ Laser System. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate device) that is not subject to PMA.
This document explicitly states: "No new indications were sought in this 510(K) and no clinical data is presented."
Therefore, the submission relies on demonstrating substantial equivalence to predicate devices rather than presenting new clinical study data to prove that the device meets specific performance acceptance criteria for its intended uses.
Given this, I cannot extract the following information as it is not present in the provided document:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth.
- Qualifications of those experts.
- Adjudication method.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
Summary of Device Acceptance and Compliance Information from the Provided Text:
The Light Age EpiCare-DUO™ Laser System received 510(k) clearance (K091625) based on demonstrating substantial equivalence to existing predicate devices:
- Light Age, Inc. EpiCare™ Alexandrite Laser System [K032991]
- Cynosure Apogee Elite [K034030]
- Candela Corp GentleLase Family of Lasers [K063074]
The reason for the 510(k) submission was a design change: adding a Neodymium (Nd) YAG capability to the existing EpiCare™ alexandrite laser system.
Stated Basis for Substantial Equivalence (in lieu of clinical studies for new indications):
- When operated in the 755 nm wavelength mode, the candidate device is identical in design and operation to the previously cleared EpiCare™ laser system.
- In the 1064 nm mode, the candidate device is substantially equivalent in operation and efficacy to the other predicate devices.
- The manufacturer states, "No new indications were sought in this 510(K) and no clinical data is presented."
- The manufacturer relies on the clinical safety record of the EpiCare™ product family, stating almost a decade of use with over 1 million treatments performed and no reports of significant patient or operator injury.
- The device is designed in accordance with both mandatory and voluntary standards, ensuring safety and effectiveness.
Relevant Performance Standards (not specific clinical acceptance criteria data):
- 21 CFR1040.10 and 21 CFR1040.11: Applicable performance standards for light-emitting products.
- Voluntary Electrical Equipment Standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-1-22.
In conclusion, this 510(k) submission for the EpiCare-DUO™ Laser System did not involve clinical studies with specific acceptance criteria as it was based on substantial equivalence for existing indications, not new ones. Therefore, the requested details regarding clinical study methodology, sample sizes, expert involvement, and ground truth establishment are not available in this document.
§ 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.