Facility

ADVANCE-ESTHETIC LLC

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3013397886
Establishment type	Repack or Relabel Medical Device; Complaint File Establishment per 21 CFR 820.198
Location	4101 Ravenswood Rd Ste 110 Fort Lauderdale, FL, US 33312
Registration status	Active · expires 2026
Parent company	Advance-Esthetic LLC (owner-operator 10053538)
Brand names	Zemits LumaGenix

Activity by year

Recalls (1)
Inspections (2)
Warning letters (1)

Devices registered here (2)

Powered Laser Surgical Instrument
Product code GEX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Product code ONF (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810

Recalls & enforcement

Class IIOngoing2023-10-09
Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standards and certification. This Recall provides correction by the firm regarding Zemits NdPrime Ya…

FDA inspections (2)

NAI2024-02-07
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
OAI2022-03-15
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2026-08-25
Warning Letter (opens in a new tab) · Fort Lauderdale Florida

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by Advance-Esthetic LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ADVANCE-ESTHETIC LLC (FEI 3013397886) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013397886-advance-esthetic-llc/

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