# K203395: Platform treatment system

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Apolo Medical Technology Co., Ltd.
- Decided: Jan 28, 2022 after 436 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K943450 (1995). 579 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 581 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200746: IPL Treatment Systems, Shanghai Apolo Medical Technology Co., Ltd. (2020) Summary page 5.
- K192856: MT One, M&T S.R.L. (2020) Summary page 5.
- K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) Summary page 6.

## Most influential descendants
- K240474: Multi-function Platform Systems   (BL-M10) (2024), 0 descendants of its own

## 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)

Source page: https://510kreport.com/device/K203395
Methodology: https://510kreport.com/methodology