Product code HPM— Ophthalmic

FDA has cleared 4 devices under product code HPM between 1978 and 2000, 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.

• 20001 clearance
• 19961 clearance
• 19911 clearance
• 19781 clearance

• Pmt Corp.1 clearance
• Keeler Optical Products , Ltd.1 clearance
• Fatswith Intl., Inc.1 clearance
• Adams Electronics, Inc.1 clearance

• K003305 — PEDIATRIC INGESTASCANAdams Electronics, Inc.·2000-12-22
• K953277 — SHADOW MEDAL LOCATORFatswith Intl., Inc.·1996-04-01
• K911886 — PMT METAL LOCATOR, MODEL 3630-1Pmt Corp.·1991-08-12
• K781892 — LOCATOR, FOREIGN BODYKeeler Optical Products , Ltd.·1978-12-04