# K150676: L-Mesitran Dressing Family II- Soft and Tulle

- Pathway: 510(k) (Traditional)
- Applicant: Theo Manufacturing BV
- Decided: Dec 23, 2015 after 282 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K053095 (2007). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053613: L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran Active, Theo Manufacturing BV (2007) Summary page 4.
- K101793: Medihoney Gel Dressing with Active Manuka Honey, Derma Sciences, Inc. (2011) Summary page 4.

## Indications for use
a) Over-The-Counter (OTC) use The L-Mesitran Dressing Family II – Soft and Tulle provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. For over the counter use, L-Mesitran Dressing Family II may be used for: - minor abrasions - lacerations - minor cuts - minor scalds and burns b) Prescription (Rx) use Under the supervision of a healthcare professional, The L-Mesitran Dressing Family II – Soft and Tulle provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. The L-Mesitran Dressing Family II is intended for the management of the following: - Diabetic foot ulcers - Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) - Pressure ulcers / sores (partial and full thickness) - 1st and 2nd degree partial thickness burns - Donor sites, and traumatic and surgical wounds L-Mesitran Soft and Tulle are to be used in conjunction with other secondary dressings.

Source page: https://510kreport.com/device/K150676
Methodology: https://510kreport.com/methodology