Product code KGL— General, Plastic Surgery

FDA has cleared 8 devices under product code KGL between 1976 and 1985, filed by 6 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.

• 19851 clearance
• 19841 clearance
• 19821 clearance
• 19812 clearances
• 19792 clearances
• 19761 clearance

• Paul B. Elder Co.3 clearances
• Waldmann Lighting Co.1 clearance
• Ultralite1 clearance
• Sylvania Lighting Products1 clearance
• National Biological Corp.1 clearance
• Dermatron Corp.1 clearance

• K852575 — WALDMANN F85/100W PUVASylvania Lighting Products·1985-08-16
• K841795 — UV 8001K, PUVA 800, PUVA 180/200 1000Waldmann Lighting Co.·1984-08-30
• K820280 — SPECTRA 305/350Ultralite·1982-03-05
• K810668 — HO-B-LITE VI UNITNational Biological Corp.·1981-04-23
• K810358 — PHOTOTHERAPY LIGHT CHAMBERPaul B. Elder Co.·1981-03-20
• K791977 — PSORALITE MARK IPaul B. Elder Co.·1979-12-28
• K791116 — PSORALITE SERIES 30,000Paul B. Elder Co.·1979-09-04
• K761094 — UVA PHOTOTHERAPY SYSTEMDermatron Corp.·1976-12-02