Product code HLW— Ophthalmic
MONOPOLAR INJECTION NEEDLE ELECTRODE
- Classification name
- Preamplifier, Battery-Powered, Ophthalmic
- Device class
- Class 2
- Regulation
- 21 CFR 886.1640
- Advisory panel
- Ophthalmic
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code HLW
FDA has cleared devices under product code HLW between 1986 and 1990, filed by 1 applicant company. 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
- 1990
- 1986
Top applicants under product code HLW
Recent clearances under product code HLW
Data sourced from openFDA. This site is unofficial and independent of the FDA.