Surgical devices · 21 CFR 872 Subpart E
Surgical Headlight Light
FDA device type “Light, Surgical Headlight”.
- Companies listing it
- 4329 makers
- Brands and models
- 65
- 510(k) clearances
- 100 in five years
- FDA name
- Light, Surgical Headlight
510(k) clearances per year, 1976–2026
Companies that list EBA
43 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Sybron Dental Specialties | United States | Maker | Dragonfly ErgoZoom · Dragonfly NEO · Dragonfly PRO · Dragonfly RDH · +7 | 203 | 2026 |
| Stryker | United States | Maker | DENTAL HEADLIGHT | 33 | 2024 |
| Changzhou Sifary Medical Technology Co., Ltd. | China | Maker | Surgical Headlight, Wireless Z, Lux-SFT, Wireless Z+ | 4 | 2026 |
| Foshan SOCO Precision Instrument Co.,Ltd. | China | Maker | Medical Headlight · model:SCML05,SCML06 | 1 | 2024 |
| Zumax Medical Co., Ltd. | China | Maker | HEADLIGHTS · HL8000 HEADLIGHT · HL8200 HEADLIGHT · HL8260 HEADLIGHT · +2 | 1 | 2026 |
| Dentlight, Inc. | United States | Maker | iZoom | 3 | 2019 |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Qibei Technology Co., Limited | China | Maker | Dental operating lamp · LD01,LD02,LD03,LD05,LD06 | — | — |
| Teleflex | United States | Maker | LIGHT · MULTIPLE SURGICAL HEADLIGHT LIGHTS · SURGICAL HEADLIGHT | — | — |
| one day dental partner | South Korea | Maker | kage Light | — | — |
| HILBRO International (Pvt) Ltd. | Pakistan | Maker | Hilbro Intl surgical headlight light | — | — |
| Hexamed Pvt Ltd | Pakistan | Maker | Dental Surgical Headlight | — | — |
| Greens Surgicals Private Limited | India | Maker | GREENS | — | — |
| Quality Aspirators | United States | Maker | Fiber Optic Headlight | — | — |
| Sunoptic Technologies LLC | United States | Maker | BRAND · Cuda · Customer brand · FIBEROPTIC HEADLIGHT SYSTEM · +1 | — | — |
| Illuco Co, LTD | South Korea | Maker | IHL-2000 | — | — |
| Bryant Medical Ltd | United Kingdom | Maker | Ignis Headlight System | — | — |
| MedDev Corporation | United States | Maker | SAME (OR "MEDDEV SURGICAL HEADLIGHT · " "MEDDEV SURGICAL HEADL | — | — |
| Xenosys Co Ltd | South Korea | Maker | L2SX5 | — | — |
| Chamfond Biotech Co., Ltd | China | Maker | Headlight | — | — |
| Elite Precision Instruments Company LLC | United States | Maker | Epic LED | — | — |
| Jiangsu Keling Medical Appliances Co.,Ltd. | China | Maker | operation light(Model:KL-LED.STR78 series, KL-LED.DTR78 series KL-LED.D78 series, KL-LED.STZ4 series, KL-LED.STZ5series) | — | — |
| OpInstruments GmbH | Germany | Maker | Medical Headlight | — | — |
| Snap On Optics | United States | Maker | Snap On Loupe Light | — | — |
| Taizhou Huangyan Guanhong Plastic Steel Products Factory | China | Maker | Light Handle Covers | — | — |
| evonos GmbH & Co. KG | Germany | Maker | — | — | — |
| Keeler Ltd | United Kingdom | Maker | — | — | — |
| RZ Medizintechnik GmbH | Germany | Maker | — | — | — |
| 鲁道夫医疗有限公司Rudolf Medical GmbH+Co.KG | Germany | Maker | — | — | — |
| Essential Dental Systems, Inc. | United States | Repacker / relabeler | Endo CSV LED Light | 15 | 2023 |
| KARL STORZ SE & Co. KG | Germany | Contract manufacturer | Headlight | 1 | 1998 |
| Olympus Corporation | Japan | Foreign exporter | — | 1 | 2007 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | DENTQ | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Unisource Shanghai Ltd. | China | Foreign exporter | LED Headlight System | — | — |
| Andau Medical Inc. | Canada | Lister | Admetec Butterfly S-EVO · Admetec Orchid · Admetec Orchid Ergo · Admetec Orchid-F · +1 | — | — |
| Black & Black Surgical Inc | United States | Repacker / relabeler | Headlight | — | — |
| Arvato SE | Germany | Repacker / relabeler | Head light | — | — |
| BFW, Inc. | United States | Repacker / relabeler | KITSILANO LED Headlight | — | — |
| Rudolf Riester GmbH & Co KG | Germany | Repacker / relabeler | K-L.E.D Surgical Headlight | — | — |
| Spiggle & Theis Medizintechnik GmbH | Germany | Repacker / relabeler | Light Surgical Headlight | — | — |
| Microsurgery Instruments, Inc. | United States | Repacker / relabeler | — | — | — |
| Tekno-Medical Optik-Chirurgie GmbH | Germany | Manufacturer | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 12 Feb 2007 | K070287 | PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 | Photonic Optische Gerate GmbH & Cokg |
| 16 Oct 1992 | K923949 | SYLVAN DENTAL HEADLIGHT SYSTEM | Sylvan Medical Fiberoptics |
| 22 Jun 1989 | K893458 | FIBEROPTIC HEADLIGHT SYSTEM | Cuda Products Co. |
| 6 Mar 1986 | K854646 | VEGA DENTAL OPERATING LIGHT | Alpine Dental Equipment Co. |
| 2 Aug 1984 | K842515 | SURGICAL HEADLIGHT | Good-Lite Co. |
| 31 Jul 1984 | K842358 | ISOLIGHT | Planmeca USA, Inc. |
| 28 Sep 1982 | K822265 | FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS | Kelleher Corp. |
| 10 Feb 1981 | K810117 | HALOGEN HEADLIGHT SYSTEM | Colmed, Ltd. |
| 3 Aug 1979 | K790807 | METALIT | Harry J. Bosworth Co. |
| 3 Aug 1979 | K790806 | PORCELIT | Harry J. Bosworth Co. |
Official records: FDA product classification for EBA · 21 CFR 872.4630.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026