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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: DermLite 1 (DL1); DermLite 3 (DL3N); DermLite Carbon (DermLite DLC); DermLite DL1 Basic (DL1B); DermLite DL100; DermLite DL200 HR; DermLite DL200 Hybrid; DermLite DL200 HYG; DermLite DL4 (DL4); DermLite DL4W; DermLite DL5 (DL5); DermLite DL5P (DL5 Plus); DermLite Foto II Pro (Foto II Pro); DermLite Foto X; DermLite GL; DermLite Handyscope; DermLite HUD2 (HUD2); DermLite Lumio (LUM); DermLite Lumio 2 (DLU2); DermLite Lumio S (DLUS); DermLite Lumio UV (LUM UV); Syris v900L
Classification Name: LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED
Product Code: KYT
Device Class: 1
Regulation Number: 880.6350
Medical Specialty: General Hospital
Registered Establishment Name: DermLite LLC
Registered Establishment Number: 3003452144
Owner/Operator: DermLite LLC
Owner/Operator Number: 9045109
Establishment Operations: Manufacturer
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