Product code HLT— Ophthalmic
DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING
- Classification name
- Preamplifier, Ac-Powered, Ophthalmic
- Device class
- Class 2
- Regulation
- 21 CFR 886.1640
- Advisory panel
- Ophthalmic
- Total cleared
- 4
- First cleared
- Most recent
Market context for product code HLT
FDA has cleared devices under product code HLT between 1978 and 1994, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1994
- 1992
- 1984
- 1978
Top applicants under product code HLT
Recent clearances under product code HLT
Data sourced from openFDA. This site is unofficial and independent of the FDA.