# K170103: Laparoscope Lens Shield Device (LENS)

- Pathway: 510(k) (Special)
- Applicant: Medeon Biodesign, Inc.
- Decided: Feb 16, 2017 after 35 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K904871 (1991). 21 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160172: Laparoscope Lens Shield Device, Medeon Biodesign, Inc. (2016) Summary page 4.

## Most influential descendants
- K192891: Laparoscope Lens Shield Device (LENS) (2019), 4 descendants of its own
- K200228: ClearCam System (2020), 3 descendants of its own
- K241796: TroCare TroKit Laparoscope Lens Wiper (CP000626) (2024), 2 descendants of its own
- K253994: TroKit Laparoscope Lens Wiper (2026), 0 descendants of its own
- K260089: TL-10 Laparoscopic Scope Cleaner (2026), 0 descendants of its own

## Indications for use
Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, for various sizes of laparoscopes including standard and bariatric laparoscope, intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

Source page: https://510kreport.com/device/K170103
Methodology: https://510kreport.com/methodology