R11 Air (Loft) R11-s-2848r1-1188i1 UP 12

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04260489020494 UDI-DI	Date13 Sep 2026Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: R11 Air (Loft)
Generic Name: Red/infrared light phototherapy unit
Model / Reference: R11-s-2848r1-1188i1 UP 12

Primary DI / UDI-DI: 04260489020494
FDA Product Code: OLI, ILY
GMDN Term: Red/infrared light phototherapy unit

Device Class: Class II
Regulation Number: 878.5400, 890.5500
GUDID distribution status: In Commercial Distribution

Other devices from KBL GmbH

KBL K11 Air Select/Plus (Loft) K11-p-2010A-552B UP 05

Class II
KBL P9 hybridSun P9 - 50h/4gx 1616 cpi us (T)

Class II
KBL K7 pureSun K7-p-46-4Hp-2s UP ep 05

Class II
KBL 6700 alpha KBL 6808 - 46/4a 1616 ep_us

Class II
KBL K9S vitaSun K9S-v-52-9s-2s UP cpi 05

Class II
KBL 7000 alpha extraSun KBL 6808 - 46p6/4g 1616 int us (T)

Class II

See all devices from KBL GmbH →

Properties

Over-the-Counter
Serial Number
Manufacturing Date

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Lot / Batch Number: No
Expiration Date: No