Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Blue LED Acne Clearing Light

Model PD5000B · PULSADERM LLC · DI 00864918000329

OLP — Over-The-Counter Powered Light Based Laser For Acne · Class II · 21 CFR 878.4810

UDILibrary device dossier · generated 2026-09-16 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

12232023-12: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 3/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 3/device2026-05: 0 reports for this device; peer average 1.5/device2026-06: 0 reports for this device; peer average 1/device1204091002030506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2023-1201
2025-0403
2025-0901
2025-1001
2026-0201
2026-0303
2026-0501.5
2026-0601
This device (reports/month)Average device in OLP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — PULSADERM LLC

Nothing in the loaded window.