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R11 Air

KBL GmbH · Model R11-s-2848r1-1188i1 UP 12 · UDI-DI 04260489020425

OLIILY Prescription
1
510(k) clearances
16
Adverse events
3
Recalls
16
Facilities

Description

Low level Light System (red light LED and infrared LED) that applies 635nm light and 880nm light for Aesthtic use and for pain indications.

Recalls

DateFirmReason
2014-05-06Advanced Photonic Systems, LLCMarketing without marketing clearance or approval.
2014-05-06Advanced Photonic Systems, LLCMarketing without marketing clearance or approval.
2014-05-06Advanced Photonic Systems, LLCMarketing without marketing clearance or approval.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.