Device product
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
Z-0606-2020
Product summary
- Firm
- Theralase Inc.
- Event
- Event 84168
- Status
- Terminated
- Classification
- Class III
- Quantity
- 41 units
- Official record key
device-enforcement:Z-0606-2020
Official wording
Reason: Device was shipped without a Unique Device Identification (UDI) label.
Code information: Serial Numbers: 3015, 3022, 3037, 3040, 3047, 3052, 3055, 3074, 3076, 3080, 3100, 3101, 3102, 3103, 3123, 3127, 3129, 3131, 3132, 3137, 3139, 3155, 3162, 3166, 3171, 3183, 3187, 3200, 3206, 3227, 3245, 3266, 3268, 3293, 3296, 3297, 3305, 3308, 3318, 3321, 3332
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, LA, MD, MN, NC, NJ, NM, NY, OR, WI and countries of AU, BH, CA, HK, JO, MX, PK, PH.
Derived failure modes
-
Unknown
Device was shipped without a Unique Device Identification (UDI) label.