# K113018: Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based Platform

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Syntech Laser CO., LTD.
- Decided: Dec 14, 2012 after 430 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: 15 generations back to K943450 (1995). 243 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 245 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080374: Biosyag Medical System, Bios S.R.L. (2008) Summary page 4.
- K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) Summary page 4.
- K024093: Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and ND:Yag Laser Systems, Lumenis, Ltd. (2003) Summary page 4.

## Most influential descendants
- K221766: Solon (2024), 0 descendants of its own

## Indications for use
Apollo V+ Medical platform / Apollo IV+ Medical Platform / Nice Station Light Based Platform, the three models have the same intended use. They 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. Er: YAG Laser handpiece: Incision, excision, ablation, vaporization of soft tissue The non-ablative treatment of facial wrinkles 2. Long pulse Nd:YAG Laser handpiece: Removal of unwanted hair, for stable long term or permanent hair reduction, and for treatment of PFB. 3. 0-Switched Nd: YAG Laser Hand piece: 1064nm wavelength Tattoo removal: Dark ink: (Black & Blue) Nevus of Ota Skin resurfacing procedures for the treatment of acne scars and wrinkles 5. IPL Handpiece: The Intense Pulse Light wavelength are 515 - 1200nm HR (Hair removal): 650 - 1200nm The removal of unwanted hair from skin types I - V, and to effect stable long-term, or permanent hair reduction in skin types I - V through selective targeting of melanin in hair follicles. SR (skin remove): 570-1200nm The treatment of benign pigmented (epidermal and cutaneous) lesions, such as warts. VR (Vascular and Pigmented Lesions Removal), 515-1200nm The treatment of benign vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of civatte; leg veins and venous malformations.

Source page: https://510kreport.com/device/K113018
Methodology: https://510kreport.com/methodology