FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HESSBURG LIGHT GUARD
K Number: K853035
·
Decision Dec 13, 1985
Classifications
1
FEI Numbers
712
Registration Numbers
712
Same Product Code
54
Applicant Total
49
Review Days
148
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HESSBURG LIGHT GUARD
- K Number
- K853035
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4750
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Visitec Co.
- Date Received
- July 18, 1985
- Decision Date
- December 13, 1985
- Product Code
- HOY
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HOY), ordered by most recent decision date.
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
FDA 510(k)
FDA Class 1
·Ophthalmic
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
FDA 510(k)
FDA Class 1
·Ophthalmic
ARCTIC PREMIER SERIES
FDA 510(k)
FDA Class 1
·Ophthalmic
GOGGLE SAFEGUARD
FDA 510(k)
FDA Class 1
·Ophthalmic
SHIELD, EYE, OPHTHALMIC
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Visitec Co.
| K Number | Device Name | ||
|---|---|---|---|
| K953394 | VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} | Oct 12, 1995 | Substantially Equivalent |
| K945114 | VISITEC SCLERAL PLUG | Feb 23, 1995 | Substantially Equivalent |
| K945738 | VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE | Feb 14, 1995 | Substantially Equivalent |
| K945172 | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS | Jan 17, 1995 | Substantially Equivalent |
| K942234 | VISITEC PRECISE-POINT | Jul 12, 1994 | Substantially Equivalent |
| K934269 | FIBEROPTIC ILLUMINATED INSTRUMENTS | May 17, 1994 | Substantially Equivalent |
| K940210 | VISITEC EYE PAD | Mar 7, 1994 | Substantially Equivalent |
| K933872 | VISI-SPEAR EYE SPONGE | Dec 27, 1993 | Substantially Equivalent |
| K923972 | OPHTHALMIC FLUID DISTRIBUTION SETS | Nov 4, 1992 | Substantially Equivalent |
| K922530 | VISITEC MICROSURGICAL SUTURE | Oct 20, 1992 | Substantially Equivalent |