510(k) · Cleared
ClearedG.o.c.c.l.e.s.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pierrel Pharma S.R.L. · NXV Diagnostic Light, Soft Tissue Detector
Cleared on Sep 15, 2015 as substantially equivalent to K090135 (Remicalm, LLC, 2009) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Sep 15, 2015
- Review
- 90 days
- Class
- Class II
- Product code
- NXV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003995 (2001). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK003995 Speculite/OralliteTrylon Corp. · 2001
- 4 generations backK060920 VelscopeLed Medical Diagnostics, Inc. · 2006
- 3 generations backK070523 Modification to: VelscopeLed Dental, Inc. · 2007
- 2 generations backK082603 Trimira Ocs 3000Remicalm, LLC · 2008
- 1 generation backK090135 Trimira Identafi 3000Remicalm, LLC · 2009
- This deviceK151630 G.o.c.c.l.e.s.Pierrel Pharma S.R.L. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003995 | Speculite/Orallite | Trylon Corp. | 2001 | — |
| −4 | K060920 | Velscope | Led Medical Diagnostics, Inc. | 2006 | — |
| −3 | K070523 | Modification to: Velscope | Led Dental, Inc. | 2007 | — |
| −2 | K082603 | Trimira Ocs 3000 | Remicalm, LLC | 2008 | — |
| −1 | K090135 | Trimira Identafi 3000 | Remicalm, LLC | 2009 | — |
| 0 (this device) | K151630 | G.o.c.c.l.e.s. | Pierrel Pharma S.R.L. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NXV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090135 | Trimira Identafi 3000Summary page 4…ng devices: Applicant Device name 510(k) Number TRIMIRA LCC TRIMIRA Identafi 3000, Remicalm LCC K090135 LED Dental VELscopeVx, LED Dental Incorporated K102083 Incorporated PIERREL Pharma… | 2009 |
| * | K102083 | Velscope VXSummary page 4…510(k) Number TRIMIRA LCC TRIMIRA Identafi 3000, Remicalm LCC K090135 LED Dental VELscopeVx, LED Dental Incorporated K102083 Incorporated PIERREL Pharma S.r.l. G.o.c.c.l.e.s. 5… | 2010 |
| † | K020091 | Optilux 501 | 2002 |
| † | K080025 | Led.L, Led.M, Led.G, Led.B | 2008 |
| † | K011154 | Elipar Freelight | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K090135.
How does its category compare?
All NXV devicesNXV Diagnostic Light, Soft Tissue Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NXV
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NXV
95in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NXV
No recall names NXV since 2007.
Adverse event reports per year · NXV
1in 2018
MAUDE reports naming product code NXV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 95 | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151630: G.o.c.c.l.e.s..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151630
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026