(88 days)
- Temporary hair reduction.
- Stable long-term, or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime.
- On all skin types (Fitzpatrick I-VI) including tanned skin.
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 circular beams with diameters of 6, 8, 10, 12, 15, 18 millimeters 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.
This submission (K024260) for the Candela GentleLASE Family of Laser Systems does not contain a study with acceptance criteria and reported device performance in the typical sense of a clinical trial demonstrating efficacy against specific metrics.
Instead, this 510(k) submission is a "Substantial Equivalence" submission. This means Candela is asserting that their new device is substantially equivalent to a previously legally marketed predicate device (Candela GentleLASE GL K994260). The "acceptance criteria" here are not performance metrics of the device against a disease condition, but rather the regulatory criteria for demonstrating substantial equivalence.
Here's how the provided information relates to your request, interpreted in the context of a 510(k) submission for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device Performance (in terms of demonstrating equivalence) |
|---|---|
| Same intended use | "The Candela GentleLASE Family of Laser Systems have the same intended use..." (page 1) |
| Similar operating principles | "...utilizes similar operating principles..." (page 1) |
| Matches key design aspects (spot size, wavelength, max fluence) | "...and matches key design aspects, including similar spot size, the same wavelength and the same maximum delivered fluence as the predicate device." (page 1) |
| Conforms to Laser Performance Standard (21 CFR 1040) | "The GentleLASE Family of laser Systems... conform to the Laser Performance Standard (21 CFR 1040)." (page 1) |
| Conforms to UL 2601 Electrical Safety Standard | "In addition the GentleLASE Family of Laser Systems conforms to the UL 2601 Electrical Safety Standard." (page 1) |
| Conforms to Harmonized Standard EN 60601-1-2 | "and with the Harmonized Standard EN 60601-1-2, Part 2 established by and required by the European Community." (page 1) |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable in the context of this 510(k) submission. This is not a clinical study involving a "test set" of patients or data to evaluate performance for efficacy. The "test set" here would refer to the tests conducted to prove compliance with safety and performance standards for the device itself, not for clinical outcomes. The document doesn't specify the sample sizes for these engineering/safety tests (e.g., how many devices were tested for electrical safety).
- Data provenance: Not applicable for clinical performance data. The data presented is related to technical specifications and regulatory compliance of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" establishment for clinical outcomes in this submission as it's not a clinical performance study. The "ground truth" for regulatory compliance is established by engineering standards and internal testing by Candela.
4. Adjudication method for the test set
- Not applicable. There is no clinical "test set" requiring adjudication.
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 is a laser device for hair reduction, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the purpose of this 510(k), the "ground truth" is compliance with established safety and performance standards (e.g., 21 CFR 1040, UL 2601, EN 60601-1-2) and demonstrating that the device meets the technical specifications (wavelength, fluence, spot size) of the predicate device. This is based on engineering measurements and documented internal testing.
8. The sample size for the training set
- Not applicable. There is no "training set" as this device does not involve machine learning or AI algorithms requiring data for training.
9. How the ground truth for the training set was established
- Not applicable for the reasons stated above.
In summary:
This 510(k) submission is focused on demonstrating substantial equivalence to an existing device rather than proving clinical efficacy through a novel study. The "acceptance criteria" discussed are regulatory and technical requirements for clearance, not clinical performance metrics from a trial. Documents like this typically do not include detailed clinical study data with specific acceptance criteria as you would find for PMA submissions or de novo applications where novel claims or technologies are being evaluated for efficacy.
§ 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.