(75 days)
The GentleLASE Family of lasers is indicated for use for the treatment of wrinkles.
The Candela GentleLASE Family of Lasers utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed to the target area via optical fiber/handpiece delivery system. The Dynamic Cooling Device, which provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces a circular beam on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece. The GentleLASE Family of Laser Systems are designed with six major components:
- High voltage power supply and modulator system
- Optical laser head
- Circulator system
- Optical delivery system
- Software control system
- Dynamic cooling device
The Candela GentleLASE Family of Laser Systems are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.
The provided text describes the Candela GentleLASE Family of Laser Systems, its intended use for the treatment of wrinkles, and its substantial equivalence to a predicate device. However, it does not include detailed information about specific acceptance criteria for device performance or a study demonstrating that the device meets those criteria, particularly in the context of clinical effectiveness for wrinkle treatment.
Here's an breakdown based on the information provided and what is missing:
The submission mainly focuses on regulatory compliance (Laser Performance Standard 21 CFR 1040, UL 2601, EN 60601-1-2) and establishing substantial equivalence to a predicate device (Candela GentleLASE GL, K994260). Substantial equivalence means it has the same intended use, similar operating principles, and matches key design aspects (spot size, wavelength, maximum delivered fluence) as a previously cleared device.
The claim for the treatment of wrinkles is stated to be "based on a controlled clinical study using a device that has been cleared for use in the market." This implies the predicate device (Candela GentleLASE GL) was proven effective for wrinkle treatment, and because the new device is substantially equivalent, it also claims this indication.
Missing Information:
The document explicitly states that the indications for use for wrinkle treatment are based on a controlled clinical study using a device that has been cleared for use in the market. This implies the predicate device (Candela GentleLASE GL, K994260) had such a study, and the new device is inheriting that claim due to substantial equivalence.
Therefore, the detailed information requested in the prompt's points 1-9 regarding the new device's performance acceptance criteria and a study proving it meets them is largely not present in the provided text. The submission focuses on substantial equivalence rather than a new standalone clinical efficacy study.
However, based on the information available and making inferences where necessary for the context of a 510(k) submission based on substantial equivalence:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance (Inferred from Substantial Equivalence Basis) |
|---|---|
| Same intended use: Treatment of wrinkles | Meets: Intended for the treatment of wrinkles |
| Similar operating principles | Meets: Utilizes an Alexandrite rod, emits pulsed energy at 755nm, optical fiber/handpiece delivery, Dynamic Cooling Device |
| Similar spot size | Meets: Matches predicate device's spot size |
| Same wavelength | Meets: 755 nanometers, same as predicate device |
| Same maximum delivered fluence | Meets: Matches predicate device's maximum delivered fluence |
| Conformance to Laser Performance Standard (21 CFR 1040) | Meets: Conforms to 21 CFR 1040 |
| Conformance to UL 2601 Electrical Safety Standard | Meets: Conforms to UL 2601 |
| Conformance to EN 60601-1-2 (Harmonized Standard) | Meets: Conforms to EN 60601-1-2 |
Please note: These "acceptance criteria" and "reported device performance" are inferred based on the claims of substantial equivalence and safety/regulatory compliance. The document does not provide specific numerical performance metrics for wrinkle reduction, nor does it define specific clinical acceptance criteria for effectiveness (e.g., "X% reduction in wrinkle severity in Y% of patients"). The effectiveness for wrinkle treatment is, by extension, claimed from the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not explicitly provided for the new device. The document states: "The indications for use for the treatment of wrinkles is based on a controlled clinical study using a device that has been cleared for use in the market." This refers to the predicate device (Candela GentleLASE GL, K994260). The details of that study are not included in this 510(k) summary.
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 explicitly provided for the new device or the underlying predicate device study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not explicitly provided for the new device or the underlying predicate device study.
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 system for medical treatment, not an AI-assisted diagnostic or interpretative system that would involve "human readers" in the context of MRMC studies for AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This pertains to an algorithm's performance, while the device is a physical laser system. The "standalone" performance here would refer to the laser's physical parameters (wavelength, fluence, spot size), which are mentioned as consistent with the predicate device. The clinical effectiveness for wrinkle treatment is derived from the predicate device's study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly provided. Given the indication of wrinkle treatment, the ground truth for effectiveness in the predicate device's study would likely involve clinical outcomes data (e.g., blinded physician assessment of wrinkles severity, patient satisfaction, photographic analysis).
8. The sample size for the training set
Not applicable. This refers to machine learning models, not a physical medical device submission based on substantial equivalence.
9. How the ground truth for the training set was established
Not applicable. This refers to machine learning models.
§ 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.