TLC-2000 Therapeutic Medical Laser System— 510(k) K151816
Substantially EquivalentTheralase, Inc.
FDA 510(k) clearance K151816 for TLC-2000 Therapeutic Medical Laser System, Substantially Equivalent on 2015-11-19. Applicant: Theralase, Inc.. Device class: 2.
Clearance details
- Applicant
- Theralase, Inc.
- Product code
- Code NHN
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Toronto, CA
Recent devices under product code NHN
view allMore clearances from Theralase, Inc.
view allRecalls naming K151816
K-number listed on FDA's recall record- Z-0606-2020 — TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
- Z-0607-2020 — TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
- Z-1266-2020 — TLC-2000 Therapeutic Medical Laser System
- Z-1326-2020 — TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
- Z-1348-2020 — TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
- Z-1353-2020 — TLC-2000 Therapeutic Medical Laser System
- Z-1354-2020 — TLC-2000 Therapeutic Medical Laser System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151816.
Data sourced from openFDA. This site is unofficial and independent of the FDA.