Limitless Cryo Spa LLC: Glypto Device, Glypto Cryo Machine;
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Limitless Cryo Spa LLC
- Product
- Glypto Device, Glypto Cryo Machine;
- Reason / hazard
- Lack of 510(k) clearance.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2026-08-24
- Code info
- All Glypto units distributed, placed, held, loaned, inventoried, or otherwise supplied by/through Limitless through the 08/11/2026 operational hold; 08/20/2026 preliminary field notice. Serial/account-specific consignee list attached or to be supplemented.
- Product quantity
- 219
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Ocean
- State
- NJ
- Country
- United States
- Event id
- 99811
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