Submission Details
| 510(k) Number | K151630 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 17, 2015 |
| Decision Date | September 15, 2015 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
G.o.c.c.l.e.s.
Sep 2015
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K151630 is an FDA 510(k) clearance for the G.o.c.c.l.e.s., a Diagnostic Light, Soft Tissue Detector (Class II — Special Controls, product code NXV), submitted by Pierrel Pharma S.R.L. (Capua, IT). The FDA issued a Cleared decision on September 15, 2015, 90 days after receiving the submission on June 17, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.6350.
Device Classification
| Product Code | NXV — Diagnostic Light, Soft Tissue Detector |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.6350 |
| Definition | To Be Used As An Aid In The Detection Or Visualization Of Abnormalities Of Intraoral Soft Tissue. An Adjunct To Traditional Intraoral Examination By Incandescent Light To Enhance The Visualization Of Oral Mucosal Abnormalities |
Manufacturer
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