(161 days)
The EpiLaser™ Normal Mode Ruby Laser is intended to effect a permanent reduction of hair in patients with skin types I-IV through selective targeting of melanin in hair follicles.
The LipiLaser® is intended to effect temporary hair reduction in skin types I-IV . The LipiLaser® is also intended to effect stable long-term, or permanent, hair reduction in skin types I-IV through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
The EpiLaser™ operates at a wavelength of 694.3 nanometers and the beam has a pulse duration of 0.2 to 3.0 milliseconds (msec). The laser energy is delivered to the treatment sites by an articulated arm. Energy fluences of 10-60 J/cm2 are achieved under conditions of intended use. A water-cooled handpiece (spot sizes of 7 or 10 mm) is held firmly against the treatment site.
This document describes the Palomar EpiLaser™ Normal Mode Ruby Laser, a device intended for permanent hair reduction.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state pre-defined acceptance criteria with numerical thresholds. Instead, it describes a clinical study that demonstrated the device's effectiveness. The core acceptance criterion, as implied by the FDA's "substantial equivalence" finding, would be that the device achieves "permanent reduction of hair." The FDA further clarifies this as "a long term, stable reduction in the number of hairs regrowing after a treatment regime," explicitly stating it "shall not permit a claim using the terms permanent elimination or permanent removal of all hair in the treated area after a treatment."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Permanent hair reduction | The study demonstrated that EpiLaser™ is a safe and effective tool for hair removal, resulting in a permanent reduction of hair. |
| Safety (no adverse events) | There was no scarring or depigmentation of the skin in any subject. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document only states "Observations of hair and skin responses were recorded prior to treatment and at 1, 3, 6, 9, 12 and 24 months after treatment." It does not specify the number of subjects included in the clinical study.
- Data Provenance: The data appears to be prospective as observations were recorded at various time points after treatment. The country of origin of the data is not specified but is presumably the United States, given the FDA submission context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not provide details on how the assessment of "permanent reduction of hair" was independently verified or by whom. It states "Observations of hair and skin responses were recorded," which could imply clinical observation by study investigators. No information about external experts or their qualifications is provided.
4. Adjudication Method for the Test Set:
No adjudication method is described.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No MRMC study was performed or mentioned. This is a medical device for hair removal, not an AI diagnostic tool, so an MRMC study would generally not be applicable.
6. Standalone Performance Study:
This device is a hardware laser system; therefore, the concept of a "standalone algorithm only" performance study is not applicable. The device's performance inherently involves the direct application of the laser by a user.
7. Type of Ground Truth Used:
The ground truth used was clinical observation and assessment of hair regrowth over a 24-month period. The FDA defines "permanent hair reduction" based on this observable outcome.
8. Sample Size for the Training Set:
This document describes a clinical study for a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI. The study described is an efficacy and safety evaluation.
9. How the Ground Truth for the Training Set was Established:
As there is no AI training set, this question is not applicable. The "ground truth" for the device's performance was established through clinical follow-up as described in point 7.
§ 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.