(436 days)
The Platform Treatment System can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. The specific indications should reference to the indications of each hand piece.
(1) IPL Handpiece
- Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen;
- Moderate inflammatory acne vulgaris;
- Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- Cutaneous lesions including scars;
- Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.
(2) Q-switched Nd: Y AG laser Handpiece (1064nm wavelength):
- Benign vascular and pigmented lesions, age spots:
- Nevus spilus:
- Tattoo removal.
(3) Long pulsed Nd:YAG Handpiece:
- Benign vascular lesions
- Superficial and deep telangiectasias (venulectasias)
- Benign cutaneous lesions
- Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
- The non-ablative treatment of facial wrinkles
- Laser skin resurfacing procedures
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
- Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
- Removal or lightening of unwanted hair (with and without adjuvant preparation)
- Treatment of pseudofolliculitis barbae (PFB)
The proposed device, Platform Treatment System, HS-900K can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. These five handpieces are (1) Intense Pulsed Light (IPL) Handpiece, (2) Q-switched Nd:YAG laser Handpiece and (3) Long pulsed Nd:YAG Handpiece. The proposed device is provided non-sterile, and not to be sterilized by the user prior to use.
The main unit consists of:
- (1) The Power supply module: Controls electrical supply to the entire system.
- (2) The Control module: Controls and coordinates the various components of the system for optimum performance. It also contains the following control features:
- a) Key switch: Used to turn on and off the power supply. (Clockwise to turn on and counter clockwise to turn off)
- b) Emerqency turn off switch: The red button found in the front panel of the machine is used to immediately shut off the machine's power supply in case of any emergency. Depressing this button will cut off the power supply to the whole system. Rotating the button in the direction of the arrow printed on its surface will disengage the button and will reengage the power supply. When this button is engaged remember to turn the key switch to the off position afterwards.
- c) The touch Screen: True color TFT LCD (Liquid Crystal Display) shows the operational settings and adjustments as well as system status is displayed on the screen.
- (3) The display module: Displays various information of the system and accept users' instruction.
- (4) High current capacitors: Delivers adequate electrical energy to guarantee sufficient power during operation.
- (5) Cooling system: Maintains a stable thermal environment for optimum performance.
- (6) Laser generator: The unit uses 110V 50/60Hz single-phase power supply. Its capability should be less than 2900W. Use a 25A (110V 50/60Hz), single-phase three-wire outlet at an international level.
The provided text is an FDA 510(k) premarket notification for a "Platform Treatment System." It details the device's characteristics, indications for use, and a comparison to predicate devices, along with non-clinical testing performed. However, there is no information presented in this document regarding acceptance criteria for clinical performance, or a study proving that the device meets such criteria.
The document explicitly states in Section VIII: "Clinical Testing It is not applicable." This means that the 510(k) submission did not include clinical trial data to demonstrate the device's performance. Instead, the submission relies on substantial equivalence to predicate devices and non-clinical testing (electrical safety and electromagnetic compatibility) to support its clearance.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and the reported device performance: No clinical performance acceptance criteria or reported performance is mentioned.
- Sample sizes used for the test set and the data provenance: No clinical test set data is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a clinical test set is mentioned.
- Adjudication method: Not applicable as there's no clinical test set.
- MRMC comparative effectiveness study: Not applicable as no clinical study was performed.
- Standalone performance (algorithm only without human-in-the-loop performance): This device is a laser/IPL system, not an AI algorithm, and no such study is mentioned.
- Type of ground truth used: Not applicable as there's no clinical test set.
- Sample size for the training set: Not applicable as there's no AI algorithm with a training set.
- How the ground truth for the training set was established: Not applicable.
The 510(k) summary focuses on demonstrating substantial equivalence based on technological characteristics and non-clinical safety/EMC testing, rather than clinical performance data.
§ 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.