Platform treatment system

Shanghai Apolo Medical Technology Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K203395
Device name
Platform treatment system
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2020-11-18
Decision date
2022-01-28
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

Indications for Use

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:YAG 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)

Intended Use

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:YAG 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)

Device Description

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. b) Emergency 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. 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 accepts 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.

Summary parsed at:2026-06-01 05:37:59 UTC

Predicate devices

3

K203395 references 3 predicate/reference devices

Cited as predicate

1

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