# K982082: Handisol Wound Healing

- Pathway: 510(k) (Traditional)
- Applicant: National Biological Corp.
- Decided: Oct 28, 1998 after 135 days
- Product code: FTC (Light, Ultraviolet, Dermatological)
- Device class: 2
- Regulation: 21 CFR 878.4630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
424 later devices descend from it; 2 cite it directly.
0 of 425 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Birtcher Model 625: named in the summary without a submission number
- (no number) R.A. Fischer UV-9 Therapy Lamp: named in the summary without a submission number

## Most influential descendants
- K040062: Levia Phototherapy System (2004), 280 descendants of its own
- K051428: Vtrac Excimer Lamp System (2005), 274 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K043377: ZENO (2005), 142 descendants of its own

## Indications for use
The National Biological Corporation Derma-Wand provides photo-therapeutic ultraviolet light. The UVB wand is indicated for dermatologic disorders such as psoriasis and vitiligo. While the UVC wand is indicated for dermatologic disorder in which bactericidal management is desired.

Source page: https://510kreport.com/device/K982082
Methodology: https://510kreport.com/methodology