FDA.report

Head-worn lamp

Definition
An electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.
GUDID devices
393
Last updated
2026-03-10 22:50:55

Related Product Codes

CodeDeviceSpecialtyClassDevices
HPPHeadlamp, Operating, Battery-OperatedOphthalmic1257
EBALight, Surgical HeadlightDental180
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital143
EIDSyringe, Restorative And Impression MaterialDental116
FCTHeadlight, Fiberoptic FocusingOphthalmic212
KZFDevice, Medical Examination, Ac PoweredGeneral Hospital15
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery12
FSTLight, Surgical, FiberopticGeneral, Plastic Surgery21
HJHLoupe, Binocular, Low PowerOphthalmic11
HKFMirror, Headband, OphthalmicOphthalmic11
HOISpectacle, MagnifyingOphthalmic11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
08057147028963LYNXUNIVET LOUPES SPALYNX2026-03-02
08057147028970LYNX PROUNIVET LOUPES SPALYNX PRO2026-03-02
00860015454782RocotoRocoto Inc.HM11 Device - MDWL1_HM112026-02-26
D943DCAM0Power Dental USAPower Dental U.S.A. Inc.DCAM2021-07-13
D943DCAM30Power Dental USAPower Dental U.S.A. Inc.DCAM32021-07-13
D943KIM10Power Dental USAPower Dental U.S.A. Inc.KIM-12022-07-12
D943KIM120Power Dental USAPower Dental U.S.A. Inc.KIM-122022-07-12
D943KIM20Power Dental USAPower Dental U.S.A. Inc.KIM-22022-07-12
D943KIM240Power Dental USAPower Dental U.S.A. Inc.KIM-242021-07-13
D943KIM30Power Dental USAPower Dental U.S.A. Inc.KIM-32022-07-12
D943KIM40Power Dental USAPower Dental U.S.A. Inc.KIM-42022-07-12
D943KIM50Power Dental USAPower Dental U.S.A. Inc.KIM-52022-07-12
D943KIM70Power Dental USAPower Dental U.S.A. Inc.KIM-72022-07-12
D943KIM80Power Dental USAPower Dental U.S.A. Inc.KIM-82022-07-12
D943KIM90Power Dental USAPower Dental U.S.A. Inc.KIM-92021-07-13
D943KIMSBK0Power Dental USAPower Dental U.S.A. Inc.KIMS-BK2022-07-12
D943KIMSGY0Power Dental USAPower Dental U.S.A. Inc.KIMS-GY2022-07-12
D943KIMV0Power Dental USAPower Dental U.S.A. Inc.KIMV2021-06-20
D943KIMV10Power Dental USAPower Dental U.S.A. Inc.KIMV-12021-07-13
D943KIMV20Power Dental USAPower Dental U.S.A. Inc.KIMV-22021-07-13
00757770410873Bausch + LombBausch & Lomb IncorporatedN0785 B2025-08-18
00194613122683MSI Precision Specialty InstrumentsMed Saver, Inc.FOHS-3000/SP2025-08-01
00194613122690MSI Precision Specialty InstrumentsMed Saver, Inc.FTIHL26001-BLAN2025-08-01
00860014100680AmimonRocoto Inc.HM11 Device - MDWL1_HM112025-06-24
00850061395016RONINRonin Surgical Corp.X72025-06-06
00860013851545C3QED, INC.QED-97002025-05-21
00860013851552Centauri 2QED, INC.QED-95002025-05-21
06941877819231EighteethChangzhou Sifary Medical Technology Co., Ltd.Lux-SFT2025-04-17
06941877819248EighteethChangzhou Sifary Medical Technology Co., Ltd.Wireless Z2025-04-17
06941877822248EighteethChangzhou Sifary Medical Technology Co., Ltd.Wireless Z+2025-04-17
00817157020832AmimonAMIMON LTDHM11 Device - MDWL1_HM112025-04-03
00814005023526RADBL25Quality Aspirators, Inc.RADBL252025-02-27
00814005023533RADBLC1Quality Aspirators, Inc.RADBLC12025-02-27
00814005023540RADFILM5Quality Aspirators, Inc.RADFILM52025-02-27
00814005023571RADHU2Quality Aspirators, Inc.RADHU22025-02-27
00814005023595RADHUM4Quality Aspirators, Inc.RADHUM42025-02-27
00814005023618RADINST1Quality Aspirators, Inc.RADINST12025-02-27
00814005024172RADC25Quality Aspirators, Inc.RADC252025-02-27
00814005024189RADFILM6Quality Aspirators, Inc.RADFILM62025-02-27
008140050242572 Pin Detachable CableQuality Aspirators, Inc.2 Pin Detachable Cable2025-02-27
00814005024288M-CZQuality Aspirators, Inc.M-CZ2025-02-27
00814005024295M-ORTTL AssemblyQuality Aspirators, Inc.M-ORTTL Assembly2025-02-27
00814005024301M-COQuality Aspirators, Inc.M-CO2025-02-27
00814005024370M-KEQuality Aspirators, Inc.M-KE2025-02-27
00814005024387M-HBQuality Aspirators, Inc.M-HB2025-02-27
00814005024394M-ORQuality Aspirators, Inc.M-OR2025-02-27
00814005024400M-QFQuality Aspirators, Inc.M-QF2025-02-27
00814005024431M-SUQuality Aspirators, Inc.M-SU2025-02-27
00814005024448M-SUTTLQuality Aspirators, Inc.M-SUTTL2025-02-27
00814005024455M-SVQuality Aspirators, Inc.M-SV2025-02-27
00814005024462M-TTLQuality Aspirators, Inc.M-TTL2025-02-27
00814005024479RADFIL1Quality Aspirators, Inc.RADFIL12025-02-27
00814005024486RADFIL2Quality Aspirators, Inc.RADFIL22025-02-27
00814005024516Spiral WrapQuality Aspirators, Inc.Spiral Wrap2025-02-27
00814005024547RADPS1Quality Aspirators, Inc.RADPS12025-02-27
00814005024554RADUSB1Quality Aspirators, Inc.RADUSB12025-02-27
00814005024738RADBL26Quality Aspirators, Inc.RADBL262025-02-27
00814005024806Loupe and Combo Case Name PlateQuality Aspirators, Inc.Loupe and Combo Case Name Plate2025-02-27
008140050254382022 Frames New to Old AdapterQuality Aspirators, Inc.2022 Frames New to Old Adapter2025-02-27
00850017626331MSIModern Surgical Instruments LLCMAX9000DK2025-02-12
00850017626348MSIModern Surgical Instruments LLCMAX9000HB2025-02-12
00840277406941MaxLite EliteRIVERPOINT MEDICAL, LLCMG3-SK-MX2024-12-17
00840277406958MaxLite EliteRIVERPOINT MEDICAL, LLCMG3-HK-MX2024-12-17
00840277406965MaxLite EliteRIVERPOINT MEDICAL, LLCMG6-SK-MX2024-12-17
00840277406972MaxLite EliteRIVERPOINT MEDICAL, LLCMG6-HK-MX2024-12-17
00840277406989MaxLite EliteRIVERPOINT MEDICAL, LLCMG8-SK-MX2024-12-17
00840277406996MaxLite EliteRIVERPOINT MEDICAL, LLCMG8-HK-MX2024-12-17
00840277407009MaxLite EliteRIVERPOINT MEDICAL, LLCM-92401-MX2024-12-17
00840277407016MaxLite EliteRIVERPOINT MEDICAL, LLCMG368-D-MX2024-12-17
00840277407030MaxLite EliteRIVERPOINT MEDICAL, LLCM-90207-MX2024-12-17
04250365155471ATMOSATMOS MedizinTechnik GmbH & Co. KGHL 21 LED2024-11-27
04250365155488ATMOSATMOS MedizinTechnik GmbH & Co. KGHL 21 LED (examination set)2024-11-27
04250365155495ATMOSATMOS MedizinTechnik GmbH & Co. KGHL 21 LED (OT set)2024-11-27
00198506073601ELMED INCORPORATEDELMED INCORPORATED98282024-11-26
00198506073489ELMED INCORPORATEDELMED INCORPORATED9802-022024-11-19
00850025993968Enova IlluminationEnova Illumination, Inc.800992024-10-29
00840183500450BR Surgical, LLCBR Surgical, LLCBR900-31902024-07-22
00857556008376BR Surgical, LLCBR Surgical, LLCBR900-31912024-07-22
00857556008529BR Surgical, LLCBR Surgical, LLCBR900-31922024-07-22