Hessburg Light Guard
FDA 510(k) K853035 · Visitec Co.
510(k) numberK853035
Submission
- Device name
- Hessburg Light Guard
- Applicant
- Visitec Co.
Sarasota, FL, US - Received
- July 18, 1985
- Decision date
- December 13, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOY – Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4750
- Specialty
- Ophthalmic
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| K971465 | National Medical Halthcare Custom Ophthalmic Kits or TraysHOY · Traditional | National Healthcare Mfg. Corp. | 06/04/1997SE |
| K944700 | Arctic Premier SeriesHOY · Traditional | Sungold Eyewear, Inc. | 12/22/1994SE |
| K944857 | Goggle SafeguardHOY · Traditional | Sellstrom Mfg. Co. | 12/15/1994SE |
| K945351 | Shield, Eye, OphthalmicHOY · Traditional | Taiwan Eva Industrial Co., Inc. | 12/13/1994SE |
| K945346 | Makrolon 2405 Goggles (Light and Dark)HOY · Traditional | Universal Massage & Tanning, Inc. | 11/22/1994SE |
| K942407 | Amcon Slip in Mydriatic SunglassesHOY · Traditional | Amcon Laboratories, Inc. | 06/06/1994SE |
| K941829 | Sun Filters/ShieldsHOY · Traditional | Klinger Eye Shields, Inc. | 05/17/1994SE |
| K930347 | Shaids Protective GlassesHOY · Traditional | Depuy, Inc. | 04/29/1994SE |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| K945114 | Visitec Scleral PlugLXP · Traditional | 02/23/1995SE |
| K945738 | Visiflex Ophthalmic Surgical Incise DrapeHMT · Traditional | 02/14/1995SE |
| K945172 | Visitec Silicone Retinal Implants/ExplantsHQX · Traditional | 01/17/1995SE |
| K942234 | Visitec Precise-PointGAP · Traditional | 07/12/1994SE |
| K934269 | Fiberoptic Illuminated InstrumentsHJM · Traditional | 05/17/1994SE |
| K940210 | Visitec Eye PadEFQ · Traditional | 03/07/1994SE |
| K933872 | Visi-Spear Eye SpongeHOZ · Traditional | 12/27/1993SE |
| K923972 | Ophthalmic Fluid Distribution SetsFPK · Traditional | 11/04/1992SE |
| K922530 | Visitec Microsurgical SutureGAR · Traditional | 10/20/1992SE |
Questions and answers
When was Hessburg Light Guard cleared by the FDA?
Hessburg Light Guard (K853035) received a 510(k) decision of Substantially Equivalent on December 13, 1985, 148 days after the submission was received.
What is the product code of K853035?
The FDA product code is HOY – Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear), a Class I (low risk) device regulated under 21 CFR 886.4750.