(87 days)
Olive Plus Diode Laser device is intended for use in dermatologic and general surgical procedures for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI) including tanned skin Skin
Permanent hair reduction is defined as the long term, stable reduction in the number of hairs re-growing when measured at 6,9,and 12 months after the completion of a treatment regime.
The Olive Plus Diode Laser system is a surgical device intended for use to remove or/and reduce un-wanted hair in Dermatologic and General Surgical procedure, emitting 810nm diode laser to the treatment area using Hand Pieces and foot switch. The laser beam penetrates through epidermis into dermis and absorbed by melanin in hair and hair follicle, producing laser photo thermal effect; conducting the energy from hair section to hair root, rising temperature of melanin and decomposing it, thus reaching effect of hair removal. During the treatment, the cooling system will operated to reduce the temperature of treatment area. Laser specification and other system features are controlled by LCD screen
This device consists of Power supply system, Central Control System, Cooling System, Laser Delivery system and safety features.
Hand piece tips are made by ABS plastic which are widely used in medical field.
The Olive Plus device is a diode laser system intended for dermatologic and general surgical procedures for hair removal and permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Measured at 6, 9, and 12 months post-treatment) | Reported Device Performance |
|---|---|
| Permanent hair reduction (long-term, stable reduction in the number of hairs re-growing) | The device's indications for use state it achieves permanent hair reduction as defined. The 510(k) submission states that the proposed device, Olive Plus, is substantially equivalent to the predicate device (K123483 Diode Laser DLH-06 Beijing Syntech Laser) in terms of its intended use, main function, technology, principal operation, and performance, including for permanent hair reduction. |
2. Sample Size and Data Provenance:
- Test Set Sample Size: No clinical performance test data was submitted or reviewed in this 510(k) application. The assessment of the device's performance relies on its substantial equivalence to a predicate device and bench testing results.
- Data Provenance: Not applicable, as no clinical performance data was provided.
3. Number of Experts and Qualifications:
- Not applicable, as no clinical performance data or expert-adjudicated ground truth was used for this submission.
4. Adjudication Method:
- Not applicable, as no clinical performance data or ground truth adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done.
6. Standalone Performance Study:
- No standalone (algorithm only without human-in-the-loop) performance study was done, as this is a physical medical device, not an AI algorithm. The device's performance claim is based on substantial equivalence to a predicate device, supported by bench testing.
7. Type of Ground Truth Used:
- The "ground truth" for the device's performance claims (specifically regarding hair reduction) is implicitly established by the substantial equivalence determination to the predicate device which has been previously cleared for these indications. For the Olive Plus, the relevant "ground truth" used for safety and effectiveness in this submission was based on bench testing against recognized standards (e.g., electrical safety, laser safety, biological evaluation, software risk management, and usability engineering) and comparison of specifications to the predicate device.
8. Sample Size for the Training Set:
- Not applicable. This device is a physical laser system, not an AI algorithm that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
§ 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.