# K151630: G.o.c.c.l.e.s.

- Pathway: 510(k) (Traditional)
- Applicant: Pierrel Pharma S.R.L.
- Decided: Sep 15, 2015 after 90 days
- Product code: NXV (Diagnostic Light, Soft Tissue Detector)
- Device class: 2
- Regulation: 21 CFR 872.6350
- 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 K003995 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090135: Trimira Identafi 3000, Remicalm, LLC (2009) Summary page 4.
- K102083: Velscope VX, Led Dental, Inc. (2010) Summary page 4.

## Indications for use
G.o.c.c.l.e.s. is intended to be used by a qualified health–care providers to enhance the identification and visualization of the oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer and premalignant dysplasia. G.o.c.c.l.e.s. eyewear is reusable filtered eyewear that is worn by a health care professional to enhance the visual effects of blue light during oral exam

Source page: https://510kreport.com/device/K151630
Methodology: https://510kreport.com/methodology