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Newdermo

Model FM-01 · Guangdong Newdermo Biotech Co.,Ltd. · DI 06974020960917

ILP — System, Communication, Non-Powered · Class I · 21 CFR 890.3700

OHS — Light Based Over The Counter Wrinkle Reduction · Class II · 21 CFR 878.4810

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

UDILibrary device dossier · generated 2026-09-14 · 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/device2025-06: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device2025-12: 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/device12040609101202030506
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
2025-0601
2025-0901
2025-1001
2025-1201
2026-0201
2026-0303
2026-0501.5
2026-0601
This device (reports/month)Average device in ILP, OHS, OLP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K223544 — cites (transitively): K162489 (d1), K200983 (d1), K212155 (d1), K221151 (d1), K222751 (d1), K152332 (d2), K152280 (d2), K171323 (d2), K171821 (d2), K183671 (d2), K190443 (d2), K190938 (d2), K200104 (d2), K083183 (d3), K122237 (d3), K131113 (d3), K110301 (d3), K120775 (d3), K140471 (d3), K150098 (d3), K163329 (d3), K103472 (d3), K162098 (d3), K170984 (d3), K180847 (d3), K180856 (d3), K120460 (d3), K030426 (d3), K030883 (d3), K090762 (d3), K072260 (d4), K072459 (d4), K043317 (d4), K060792 (d4), K123999 (d4), K083580 (d4), K092800 (d4), K111286 (d4), K121435 (d4), K141308 (d4), K130225 (d4), K133896 (d4), K170111 (d4), K050216 (d5), K051255 (d5), K062991 (d5), K081307 (d5), K093963 (d5), K060653 (d5), K080591 (d5), K101190 (d5), K110735 (d5), K072767 (d6) — cited as predicate by K241857, K242385, K242638, K243040, K243423, K243492, K243555, K243978, K251012, K251042, K251667, K252093, K252264, K253054, K253073, K253400, K253874

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Guangdong Newdermo Biotech Co.,Ltd.

Nothing in the loaded window.