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

LED Light Therapy Mask

Model RB-008J · Shenzhen Rainbow Technology Co.,Ltd · DI 06978368600030

ILY — Lamp, Infrared, Therapeutic Heating · Class II · 21 CFR 890.5500

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 2026-09-13 · 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.

24682019-03: 0 reports for this device; peer average 1.67/device2019-07: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 2/device2020-04: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 4/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 4/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 2.25/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 1.5/device2025-07: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 1.25/device2025-10: 0 reports for this device; peer average 1.75/device2025-11: 0 reports for this device; peer average 4/device2025-12: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 4.67/device2026-03: 0 reports for this device; peer average 8/device2026-05: 0 reports for this device; peer average 1.5/device2026-06: 0 reports for this device; peer average 2/device030710020304070103120304050611120203040506070910111202030506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0301.67
2019-0702
2019-1001
2020-0202
2020-0302
2020-0402
2021-0701
2023-0101
2023-0302
2023-1201
2024-0302
2024-0404
2024-0502
2024-0602
2024-1101
2024-1201
2025-0204
2025-0302
2025-0402.25
2025-0502
2025-0601.5
2025-0701.5
2025-0901.25
2025-1001.75
2025-1104
2025-1201
2026-0204.67
2026-0308
2026-0501.5
2026-0602
This device (reports/month)Average device in ILY, OHS, OLP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K243423 — cites (transitively): K160691 (d1), K223544 (d1), K230351 (d1), K241102 (d1), K241857 (d1), K124042 (d2), K142246 (d2), K162489 (d2), K200983 (d2), K212155 (d2), K221151 (d2), K222751 (d2), K190443 (d2), K203271 (d2), K220168 (d2), K162652 (d2), K201906 (d2), K080591 (d3), K131461 (d3), K132833 (d3), K152332 (d3), K121435 (d3), K130065 (d3), K141308 (d3), K142794 (d3), K120775 (d3), K180847 (d3), K180856 (d3), K152280 (d3), K171323 (d3), K103472 (d3), K131251 (d3), K161654 (d3), K171821 (d3), K202390 (d3), K183671 (d3), K190938 (d3), K200104 (d3), K072260 (d4), K060653 (d4), K093963 (d4), K093964 (d4), K101190 (d4), K110735 (d4), K083183 (d4), K122237 (d4), K131113 (d4), K110301 (d4), K032239 (d4), K140471 (d4), K150098 (d4), K163329 (d4), K162098 (d4), K123999 (d4), K170111 (d4), K133896 (d4), K170984 (d4), K120460 (d4), K030426 (d4), K030883 (d4), K090762 (d4), K191629 (d4), K192295 (d4), K072767 (d5), K070739 (d5), K080964 (d5), K072459 (d5), K043317 (d5), K060792 (d5), K083580 (d5), K092800 (d5), K111286 (d5), K130225 (d5), K172555 (d5), K050216 (d6), K051255 (d6), K062991 (d6), K081307 (d6) — cited as predicate by K250880, K253712

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

Manufacturer compliance record — Shenzhen Rainbow Technology Co.,Ltd

Nothing in the loaded window.