# K072344: Apl Medical System

- Pathway: 510(k) (Traditional)
- Applicant: Bios S.R.L.
- Decided: Dec 3, 2007 after 104 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: 9 generations back to K910422 (1992). 154 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042000: Modified MSQ Family of Lovely Light/Laser Systems, Msq (M2), Ltd. (2004) Summary page 1.
- K033946: Lovely System, Msq (M2), Ltd. (2004) Summary page 1.

## Most influential descendants
- K153229: Superbium (2016), 2 descendants of its own
- K080374: Biosyag Medical System (2008), 2 descendants of its own
- K113018: Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based Platform (2012), 1 descendant of its own
- K252561: BTL-754FF (2026), 0 descendants of its own
- K221766: Solon (2024), 0 descendants of its own

## Indications for use
The APL MEDICAL SYSTEM is a modular multi-laser and multi-use device and are intended for use in aesthetic, cosmetic, and surgical applications. It is used to treat common imperfections and lesions of skin and body, including: 1. The removal of unwanted hair and to effect stable long-term or permanent hair reduction 2. Laser skin treatment procedures for the treatment of: * Acne scars * Wrinkles 3. Incision, excision, ablation, vaporization of soft tissue 4. The non-ablative treatment of facial wrinkles, such as, but not limited to: * Periocular wrinkles · Perioral wrinkles 5. Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions 6. Treatment of capillaries, teleangiectasies and vascular lesions 7. Treatment of vitiligo and psoriasis The equipment should only be used under medical supervision.

Source page: https://510kreport.com/device/K072344
Methodology: https://510kreport.com/methodology